Device for automatically inserting and manipulating a medical tool into and within a bodily lumen

ABSTRACT

A compact robotic device for driving movement of two or more elongate surgical tools configured for a telescopic arrangement when said two or more elongate surgical tools are at least partially received within said device, the device comprising: a housing comprising walls which define an inner volume including at least two inner pathways for accommodating the two or more elongate surgical tools; the housing encasing: a plurality of motors, and two or more tool actuation assemblies configured at a position of each of the two or more inner pathways; the actuation assemblies driven by the plurality of motors and configured to operably contact an elongate surgical tool at least partially received in the inner pathway to at least one of advance, retract and/or roll said elongate surgical tool.

RELATED APPLICATIONS

This application is a Continuation-in-Part (CIP) of PCT PatentApplication No. PCT/IL2020/051226 filed on Nov. 26, 2020 which claimsthe benefit of priority under 35 USC § 119(e) of U.S. Provisional PatentApplication Nos. 62/941,842 filed on Nov. 28, 2019, and 63/082,508 filedon Sep. 24, 2020. The contents of the above applications are allincorporated by reference as if fully set forth herein in theirentirety.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to automatedactuation of surgical tools inserted into a bodily lumen.

U.S. Pat. No. 10,543,047 discloses “A robotic instrument driver forelongate members includes a first elongate member, and at least onemanipulator mechanism configured to manipulate the first elongatemember, and at least one articulating drive configured to articulate thefirst elongate member, positionable on a bed and beside a patient accesssite. The manipulator and articulating drive are positioned relative toeach other a distance less than the insertable length of the firstelongate member, stationary in position.”

SUMMARY OF THE INVENTION

According to an aspect of some embodiments there is provided a compactrobotic device for driving and manipulating movement of one or moreelongate surgical tools, comprising:

at least one motor;

at least one tool-moving element driven by the at least one motor, thetool-moving element positioned and configured to operably contact a toolat least partially received in the robotic device to advance, retractand/or rotate the elongate surgical tool; and

a device housing shaped and sized to encase the at least one motor andthe at least one tool-moving element.

In some embodiments, the at least one motor and the at least onetool-moving element are confined within walls of the housing, andwherein only the one or more elongate surgical tools, when receivedwithin the device, extend outwardly from the walls of the housing.

In some embodiments, walls of the housing define an inner volume of lessthan 2800 cm{circumflex over ( )}3 and wherein the device has a weightof less than 850 grams. In some embodiments, walls of the housing defineat least one entry aperture through which the elongate surgical tool isinserted into the device and at least one exit aperture through whichthe elongate surgical tool exits the device.

In some embodiments, walls of the housing define at least two entryapertures and at least two exit apertures for at least two elongatesurgical tools. In some embodiments, the device comprises an anchoringlocation for a proximal portion of the elongate surgical tool, whereinthe anchoring location and an entry aperture for the elongate surgicaltool are aligned along a similar wall of the housing so that a segmentof the elongate surgical tool extending externally to the housing andbetween the anchoring location and the entry aperture forms a U-shapedcurve outside the housing.

In some embodiments, the housing comprises a designated elongate shaftfor the elongate surgical tool to extend through, the at least one toolmoving element positioned adjacent the shaft and protruding inside theshaft to operably contact the elongate surgical tool.

In some embodiments, the at least one tool-moving element comprises aset of opposing wheels configured to rotate to advance or retract theelongate surgical tool within the shaft.

In some embodiments, the shaft is connected to a gear which when rotatedrotates the shaft along with the at least one tool-moving element andthe tool received therein about the shaft long axis, thereby rolling thetool with the at least one tool-moving element.

In some embodiments, an inner contour of the shaft is shaped to match anouter contour of the at least one tool-moving element at theirinterface.

In some embodiments, the device comprises an anchoring location for aproximal portion of the elongate surgical tool, the anchoring locationincluding a holder for holding a proximal portion of the elongatesurgical tool, while a more distal portion of the elongate surgical toolis received within the designated elongate shaft.

In some embodiments, one of the motors is configured to drive rotationof the holder and of the elongate shaft, thereby rolling the elongatesurgical tool at two spaced apart locations along the length of theelongate surgical tool.

In some embodiments, a bottom wall of the housing is saddle shaped.

In some embodiments, a bottom wall of the housing is flat.

In some embodiments, dimensions of the housing include a height shorterthan 30 cm, a width shorter than 30 cm, a length shorter than 30 cm.

In some embodiments, the housing, at the entry aperture and/or at theexit aperture, comprises a conically shaped protrusion having a roundedexternal lip.

In some embodiments, the housing comprises a removable or movable coverproviding access to the one or more elongate surgical tools loaded ontothe device.

In some embodiments, the device is configured to drive and manipulatemovement of at least one of a guidewire and a microcatheter.

According to an aspect of some embodiments there is provided a surgicalsystem comprising:

a robotic device for example as described herein, and an add-on unit fordriving movement of a guiding catheter, the add-on unit mechanicallyattachable to the housing of the robotic device.

In some embodiments, the system comprises a remote control device incommunication with a controller of the robotic device. In someembodiments, the system comprises an imaging modality in communicationwith a controller of the robotic device.

According to an aspect of some embodiments there is provided an assemblyfor driving linear movement and rotational movement of an elongatesurgical tool, comprising:

a shaft comprising a slot in communication with a central lumen of theshaft, the lumen extending along the shaft long axis;

a set of wheels positioned opposing each other and aligned on two sidesof the slot, the wheels at least partially extending through aperturesin the elongate shaft and into the slot to contact an elongate surgicaltool received therein;

a gear positioned and configured, when rotated, to rotate the shaftalong with the set of wheels about the shaft long axis.

In some embodiments, the gear is linearly aligned with the shaft and isco-axial with the shaft.

In some embodiments, the assembly comprises a motor positioned andconfigured to drive rotation of the wheels, the motor positioned andconfigured to rotate with the shaft when the shaft is rotated.

In some embodiments, the gear comprises a slot on its circumference, theslot linearly aligned with the slot of the shaft.

In some embodiments, inner walls of the shaft which define the centrallumen are contoured to match at least a portion of an external contourof at least one of the wheels of the set of wheels.

In some embodiments, the assembly comprises motor transmission incontact with the gear and configured to rotate the gear.

In some embodiments, each wheel of the set of wheels is arranged to lieon a plane that is substantially perpendicular to a plane defined by theslot.

In some embodiments, when the assembly is rotated about the shaft longaxis, the set of wheels rotates along so that each wheel of the set ofwheels remains lying on the plane that is substantially perpendicular tothe plane defined by the slot.

According to an aspect of some embodiments there is provided a method ofusing a surgical robotic device for manipulation of at least oneelongate surgical tool, comprising:

providing a robotic device shaped and sized to be placed adjacent or ona surgical bed;

loading at least one elongate surgical tool onto the device;

controlling manipulation of the at least one elongate surgical tool bythe robotic device via a remote control interface to carry out asurgical procedure; and

disposing the robotic device along with the at least one elongatesurgical tool following the surgical procedure.

In some embodiments, the robotic device comprises:

one or more motors;

one or more tool-moving elements driven by the one or more motors;

wherein loading places the at least one elongate surgical tool in directoperable contact with the one or more tool-moving elements, and the oneor more tool-moving elements are in direct operable contact with the oneor more motors. In some embodiments, the robotic device is not coveredby a sterile drape.

In some embodiments, the method comprises introducing the at least oneelongate surgical tool into the body and allowing body fluids throughthe elongate surgical tool and into the robotic device.

According to an aspect of some embodiments there is provided a method ofusing a surgical robotic device for manipulation of at least oneelongate surgical tool, comprising:

providing a robotic device shaped and sized to be attached to apatient's limb;

attaching the robotic device onto the patient's limb;

loading the at least one elongate surgical tool onto the device; and

controlling manipulation of the at least one elongate surgical tool bythe robotic device to carry out a surgical procedure.

In some embodiments, the limb is one of: a patient's leg where therobotic device is attached to the thigh, a patient's arm where therobotic device is attached adjacent the wrist.

In some embodiments, the method comprises forming an incision in thepatient's groin and introducing, using the robotic device, the at leastone elongate surgical tool through the incision.

In some embodiments, attaching comprises strapping the robotic deviceonto the limb.

According to an aspect of some embodiment there is provided a method ofcontrolling a usable length of an elongate surgical tool, comprising:

providing a robotic device comprising a housing;

loading the elongate surgical tool onto the robotic device such that theelongate surgical tool is held at a first location along the length ofthe elongate surgical tool and slidably held at a second location alongthe length of the elongate surgical tool; wherein a segment of the toolextending between the first and second locations forms a curve; and

sliding the elongate surgical tool at the second location to shorten orlengthen a distance between a maximal point of the curve and the housingof the robotic device to control the length of the elongate surgicaltool.

In some embodiments, the method comprises controlling, via theshortening or lengthening, a length of a distal segment of the elongatesurgical tool which extends from the robotic device housing to a targetpoint inside the patient's body.

According to an aspect of some embodiments there is provided a compactrobotic device for driving and manipulating movement of at least twoelongate surgical tools, comprising:

a housing comprising:

-   -   at least one motor;    -   at least two assemblies, each assembly configured for driving        linear movement and/or rotation of one of the at least two        elongate surgical tools, each assembly comprising tool-moving        elements driven by the at least one motor or associated        transmission;

wherein the housing defines a volume of less than 2800 cm{circumflexover ( )}3 and has a weight of less than 850 grams.

According to an aspect of some embodiments there is provided a compactrobotic device for driving and manipulating movement of at least oneelongate surgical tool, comprising:

a housing comprising:

-   -   at least one motor;    -   a first tool-moving element driven by the at least one motor,        the tool-moving element positioned and configured to operably        contact an elongate surgical tool at least partially received in        the robotic device to advance or retract the elongate surgical        tool; and    -   a second tool-moving element driven by the at least one motor        and configured to roll the elongate surgical tool about the long        axis of the elongate surgical tool.

In some embodiments, the housing comprises a shaft for the elongatesurgical tool to extend through, the first tool-moving element at leastpartially protruding into the shaft to contact the elongate surgicaltool.

In some embodiments, inner walls of the shaft are contoured to match atleast a portion of an external contour of the first tool-moving element.

In some embodiments, the first tool-moving element comprises at leastone pair of wheels which advance or retract the elongate surgical tooldependent on the wheel direction of rotation.

In some embodiments, the second tool-moving element comprises a gearaligned linearly along the shaft and configured to rotate the shaft.

According to some embodiments, there are provided advantageous medicaldevices for inserting and advancing a medical tool within bodilylumen(s), wherein the devices are configured to advance the medical toolin a linear movement and/or rotational movement. In some embodiments,the advantageous devices disclosed herein allow the insertion andadvancement of more than one medical tool, separately or simultaneously,while being small in size, thereby configured to be mounted onto thesubject body, or at least in close proximity thereto. In someembodiments, the devices disclosed herein are configured to operateautomatically and/or controlled manually by a user, utilizing a remotecontroller. In some embodiments, further provided are systems whichinclude the disclosed devices and methods of using the same in variousmedical procedures.

According to some embodiments, there is provided a medical device foradvancing and inserting a medical tool into a bodily lumen, the devicebeing configured to be mounted on the subject's body or to be positionedin close proximity thereto, and including: a housing configured forpositioning the medical device on the body of the subject or in closeproximity to the subject's body; at least one movement control unitcomprising at least one actuator configured for linearly advancing themedical tool and at least one rotational actuator configured forrotating the medical tool; wherein the at least one rotational actuatorand the at least one linear actuator are activated simultaneously and/orand independently from each other.

According to some embodiments, the device may further include acontroller configured to activate the at least one linear actuator andthe at least one rotational actuator. According to some embodiments, thecontroller may be configured for manual operation by a user. Accordingto some embodiments, the controller may be configured for receivingcommands from a processor. In some embodiments, the device may beautonomously computer controlled.

According to some embodiments, the at least one linear actuator and theat least one rotational actuator may have one or more common actuators.

According to some embodiments, the at least one linear actuator mayinclude an actuator selected from: a DC motor, an AC motors, a steppermotors, an electromagnetic actuator, a piezoelectric actuator, apneumatic actuator, an hydraulic actuator, or any combination thereof.

According to some embodiments, the at least one rotational actuator mayinclude an actuator selected from: a DC motor, an AC motors, a steppermotors, an electromagnetic actuator, a piezoelectric actuator, apneumatic actuator, an hydraulic actuator, or any combination thereof.In some embodiments, the medical device is disposable. In someembodiments, the medical device is miniature in size. In someembodiments, the medical device is lightweight.

According to some embodiments, the medical tool may be selected from: aguidewire, micro-catheter, balloon catheter, guiding catheter, stentingcatheter, embolization catheter, stent retriever device, and the like,or any combination thereof.

According to some embodiments, the body lumen may be selected from ablood vessel, urethra and trachea, gastric anatomy, and the like.According to some embodiments, the device may include more than onemovement control unit, wherein each control unit may be configured tolinearly advance and/or rotate a separate medical tool or combination oftwo or more motors can perform a decoupled or combined motion of themedical tools.

According to some embodiments, the device may include two movementcontrol units, wherein a first movement control unit is configured tolinearly advance and/or rotate a first medical tool, and a secondmovement control unit configured to linearly advance and/or rotate asecond medical tool.

According to some embodiments, the first medical tool may be a guidewireand the second medical tool may a catheter.

According to some embodiments, the first medical tool may be configuredto advance through a lumen of the second medical tool.

According to some embodiments, the device may be further configured toallow control over the tip parameters of the medical tool.

According to some embodiments, the movement control unit may include atleast two discs opposing each other along a portion of their externalcircumference, such that the medical tool is capable of being placed ina space formed therebetween, while maintaining at least partial contactwith at least one of the discs, whereby upon spinning of said discs, themedical tool linearly advances. The surface of the externalcircumference of the discs may be rough, soft, smooth, coated, spongy,hydrophilic, hydrophobic, or with other characteristics that mayoptimize the interaction with the medical tool. The driving discs may beassembled in such a way that the medical tool is not actuated along astraight line, but along a curved route, thus allowing for higherdriving force and higher rotational moment.

According to some embodiments, the medical device may further include apower source.

According to some embodiments, the device may be configured to linearlyadvance the medical tool at a constant or varying rate (velocity).

According to some embodiments, the device may be configured toautomatically insert and advance the medical tool into the bodily lumen.

According to some embodiments, there is provided a system for insertinga medical tool into a bodily lumen, the system includes: a medicaldevice for inserting the medical tool into the bodily lumen, the devicebeing configured for positioning on or in close proximity to a body of asubject, and comprising: at least one movement control unit comprisingat least one actuator configured for linearly advancing the medical tooland at least one rotational actuator configured for rotating the medicaltool; a controller configured to activate the at least one linearactuator and the at least one rotational actuator, said controller isconfigured to activate the at least one rotational actuator and the atleast one linear actuator at least one of simultaneously andindependently from each other; and a processor configured to providecommands to said controller.

According to some embodiments, the controller may be configured formanual operation by a user.

According to some embodiments, the controller may include activatingbuttons, selected from: press buttons, sliding buttons, joystick, or anycombination thereof.

According to some embodiments, the system disclosed herein is used forautomatically inserting and advancing the medical tool into the bodilylumen in a medical procedure.

According to some embodiments, the medical procedure may include anendovascular procedure, selected from coronary, peripheral and cerebralendovascular procedures, gastric procedures, procedures in the urinaltract and in procedures in the respiratory tract.

According to some embodiments, the system may further include or beconfigured to operate in conjunction with an imaging device. Accordingto some embodiments, the imaging device may be selected from: X-raydevice, fluoroscopy device, CT device, cone beam CT device, CTfluoroscopy device, MRI device and ultrasound device. According to someembodiments, there is provided a method for inserting and advancing amedical tool into a bodily lumen, the method comprising: mounting andsecuring the medical device disclosed herein on a subject's body orpositioning the medical device in close proximity to the subject's body,and advancing the medical tool into the bodily lumen of the subject. Insome embodiments, the method is automatic (i.e. advancing of the medicaltool is performed automatically by the medical device).

According to some embodiments, there is provided a body mountablemedical device for inserting a medical tool into a bodily lumen, thedevice includes: a housing configured for positioning on a body of asubject and securing thereto; at least one linear actuator configuredfor linearly advancing the medical tool; at least one rotationalactuator configured for rotating the medical tool; a controllerconfigured to activate the at least one linear actuator and the at leastone rotational actuator; wherein the controller is configured toactivate the at least one rotational actuator and the at least onelinear actuator at least one of simultaneously and independently fromeach other.

According to some embodiments, the guidewire and microcatheter, enteringand exiting the device from the rear and front end, advantageously allowthe motion of a microcatheter over the guidewire without having themicrocatheter drive impair the guidewire drive.

Certain embodiments of the present disclosure may include some, all, ornone of the above advantages. One or more other technical advantages maybe readily apparent to those skilled in the art from the figures,descriptions, and claims included herein. Moreover, while specificadvantages have been enumerated above, various embodiments may includeall, some, or none of the enumerated advantages.

According to an aspect of some embodiments there is provided a medicaldevice for advancing and inserting a medical tool into a bodily lumen,comprising: a housing configured for positioning the medical device on aor in close proximity to a body of a subject and securing thereto; atleast one movement control unit comprising at least one actuatorconfigured for linearly advancing the medical tool and at least onerotational actuator configured for rotating the medical tool; whereinthe at least one rotational actuator and the at least one linearactuator are activated simultaneously and/or and independently from eachother.

In some embodiments, the device comprises a controller configured toactivate the at least one linear actuator and the at least onerotational actuator.

In some embodiments, the controller is configured for manual operationby a user.

In some embodiments, the controller is configured for receiving commandsfrom a processor.

In some embodiments, the at least one linear actuator and the at leastone rotational actuator have one or more common actuators.

In some embodiments, the at least one linear actuator comprises anactuator selected from: a DC motor, an AC motors, a stepper motors, anelectromagnetic actuator, a piezoelectric actuator, pneumatic actuator,hydraulic actuator, or any combination thereof.

In some embodiments, the at least one rotational actuator comprises anactuator selected from: a DC motor, an AC motors, a stepper motors, anelectromagnetic actuator, a piezoelectric actuator, pneumatic actuator,hydraulic actuator, or any combination thereof.

In some embodiments, the medical device is disposable.

In some embodiments, the medical tool is selected from: a guide wire,micro-catheter, balloon catheter, a guiding catheter, stent, retrievaldevice, or any combination thereof.

In some embodiments, the body lumen is selected from, a blood vessel,urethra, trachea and gastrointestinal.

In some embodiments, the device comprises more than one movement controlunit, wherein each control unit is configured to linearly advance and/orrotate a separate medical tool.

In some embodiments, the device comprises two movement control units,wherein a first movement control unit is configured to linearly advanceand/or rotate a first medical tool, and a second movement control unitconfigured to linearly advance and/or rotate a second medical tool.

In some embodiments, the first medical tool is a guidewire and thesecond medical tool is a catheter.

In some embodiments, the first medical tool is configured to advancethrough a lumen of the second medical tool.

In some embodiments, the device is further configured to allow controlover the tip parameters using additional actuator of the medical tool.

In some embodiments, the movement control unit comprises at least twodiscs opposing each other along a portion of their externalcircumference, such that the medical tool is capable of being placed ina space formed therebetween, while maintaining at least partial contactwith at least one of the wheels whereby upon spinning of the discs, themedical tool linearly advances. In some embodiments, the devicecomprises a power source.

In some embodiments, the device is configured to linearly advance themedical tool at a constant or varying rate (velocity).

In some embodiments, the device is configured to automatically insertand advance the medical tool into the bodily lumen.

According to an aspect of some embodiments there is provided a systemfor inserting a medical tool into a bodily lumen, the system comprising:a medical device for inserting the medical tool into the bodily lumen,the device comprising: a housing configured for positioning the medicaldevice on a body of a subject or in close proximity thereto, andsecuring thereto; at least one movement control unit comprising at leastone actuator configured for linearly advancing the medical tool and atleast one rotational actuator configured for rotating the medical tool;a controller configured to activate the at least one linear actuator andthe at least one rotational actuator, the controller is configured toactivate the at least one rotational actuator and the at least onelinear actuator at least one of simultaneously and independently fromeach other; and a processor configured to provide commands to thecontroller.

In some embodiments, the controller is configured for manual operationby a user.

In some embodiments, the controller comprises activating buttons,selected from: press buttons, sliding buttons, joystick, or anycombination thereof.

In some embodiments, the at least one linear actuator and the at leastone rotational actuator have one or more common actuators.

In some embodiments, the at least one linear actuator comprises anactuator selected from: a DC motor, an AC motors, a stepper motors, anelectromagnetic actuator, a piezoelectric actuator, a pneumaticactuator, an hydraulic actuator, or any combination thereof.

In some embodiments, the at least one rotational actuator comprises anactuator selected from: a DC motor, an AC motors, a stepper motors, anelectromagnetic actuator, a piezoelectric actuator, a pneumaticactuator, an hydraulic actuator, or any combination thereof.

In some embodiments, the medical device is disposable.

In some embodiments, the medical tool is selected from: a guide wire,micro-catheter, a guiding catheter and balloon catheter.

In some embodiments, the body lumen is selected from, a blood vessel,urethra, gastric and trachea.

In some embodiments, the system comprises two movement control units,wherein a first movement control unit is configured to linearly advanceand/or rotate a first medical tool, and a second movement control unitconfigured to linearly advance and/or rotate a second medical tool. Insome embodiments, the first medical tool is a guidewire and the secondmedical tool is a catheter.

In some embodiments, the system is configured for automaticallyinserting and advancing the medical tool into the bodily lumen in amedical procedure.

In some embodiments, the medical procedure is selected from coronary,peripheral, and cerebral endovascular procedures, gastric procedure,urinal procedures and respiratory tract procedures.

In some embodiments, the system further comprises an imaging device.

In some embodiments, the imaging device is selected from: Xray device,fluoroscopy device, CT device, cone beam CT device, CT fluoroscopydevice, MRI device and ultrasound device.

According to an aspect of some embodiments there is provided a methodfor inserting and advancing a medical tool into a bodily lumen, themethod comprising: positioning a medical device on or in close proximityto a body of a subject, the device comprising: a housing configured forpositioning the medical device on or in close proximity to a body of asubject and securing thereto; at least one movement control unitcomprising at least one actuator configured for linearly advancing themedical tool and at least one rotational actuator configured forrotating the medical tool; wherein the at least one rotational actuatorand the at least one linear actuator are activated simultaneously and/orand independently from each other; and; advancing the medical tool intothe bodily lumen of the subject.

In some embodiments, the medical tool is selected from: a guidewire, amicro-catheter, a guiding catheter and a balloon catheter.

In some embodiments, the body lumen is selected from, a blood vessel,urethra and trachea.

In some embodiments, advancing of the medical tool is performedautomatically by the medical device.

According to an aspect of some embodiments there is provided a medicaldevice for inserting a medical tool into a bodily lumen, comprising: ahousing configured for positioning on a body of a subject or in closeproximity to the subject and securing thereto; at least one linearactuator configured for linearly advancing the medical tool; at leastone rotational actuator configured for rotating the medical tool; acontroller configured to activate the at least one linear actuator andthe at least one rotational actuator; wherein the controller isconfigured to activate the at least one rotational actuator and the atleast one linear actuator at least one of simultaneously andindependently from each other.

In some embodiments, the controller is configured for manual operationby a user.

In some embodiments, the controller is configured for receiving commandsfrom a processor.

In some embodiments, the controller is configured to receive commandsfrom wireless remote controller.

In some embodiments, the wireless remote controller is a Wi-Fi remotecontroller, and Bluetooth remote controller.

In some embodiments, the at least one linear actuator and the at leastone rotational actuator have one or more common actuators.

In some embodiments, the at least one linear actuator comprises at leastone piezoelectric actuator.

In some embodiments, the at least one rotational actuator comprises atleast one piezoelectric actuator.

According to an aspect of some embodiments there is provided a compactrobotic device for driving movement of two or more elongate surgicaltools when the two or more elongate surgical tools are at leastpartially received within the device, the device comprising:

a housing comprising walls which define an inner volume including atleast two inner pathways for accommodating the two or more elongatesurgical tools

the housing encasing:

-   -   a plurality of motors;    -   two or more tool actuation assemblies configured at a position        of each of the two or more inner pathways; the actuation        assemblies driven by the plurality of motors and configured to        operably contact an elongate surgical tool at least partially        received in the inner pathway to at least one of advance,        retract and/or roll the elongate surgical tool.

In some embodiments, each of the two or more inner pathways extendsacross the inner volume between an entry aperture and an exit aperture,the entry aperture and the exit aperture being configured on oppositewalls of the device housing and in communication with the inner volume.

In some embodiments, no inner barrier exists between the two or moreinner pathways such that the two or more tool actuation assemblies andthe plurality of motors all share the inner volume with no separationtherebetween.

In some embodiments, at least one fixation location is definedexternally to the walls of the housing for securing a proximal end of anelongate surgical tool to the housing.

In some embodiments, the at least one fixation location is located atone of the exit apertures, such that an elongate surgical tool exitingthe inner volume through the exit aperture is led into a lumen of aproximal end of a second elongate surgical tool, forming a telescopicarrangement of the two tools.

In some embodiments, the at least one fixation location and one of theat least two entry apertures are defined along the same wall of thehousing such that an elongate surgical tool secured to the device at theat least one fixation location forms a curve before entering the innervolume through the at least one entry aperture.

In some embodiments, the two or more inner pathways are parallel to eachother and have a similar axial extent.

In some embodiments, a distance between long axes of the inner pathwaysis shorter than 10 cm.

In some embodiments, the tool actuation assemblies are both confinedwithin the walls of the housing, and wherein only portions of the two ormore elongate surgical tools, when received within the device, extendoutwardly from the walls of the housing to a distance of at least 1 cmaway from the housing.

In some embodiments, the inner volume is smaller than 2800 cm{circumflexover ( )}3 and wherein the device has a weight of less than 850 grams.

In some embodiments, the plurality of motors comprises 3-5 motors.

In some embodiments, each of the actuation assemblies comprises:

a designated elongate shaft extending axially along at least a portionof a length of the inner pathway for the elongate surgical tool toextend through; and

at least one pair of wheels positioned adjacent the shaft and protrudinginside the shaft to operably contact the elongate surgical tool receivedwithin the shaft.

In some embodiments, each of the actuation assemblies comprises aplurality of wheels pairs, each wheel pair comprising a set of opposingwheels arranged to define the inner pathway therebetween.

In some embodiments, the at least one pair of wheels comprises a set ofopposing wheels configured to rotate to advance or retract the elongatesurgical tool within the shaft.

In some embodiments, the shaft is connected to a gear which when rotatedrotates the shaft along with the plurality of wheels and with theelongate surgical tool received therein about the shaft long axis,thereby rolling the elongate surgical tool.

In some embodiments, dimensions of the housing include a height shorterthan 30 cm, a width shorter than 30 cm, a length shorter than 30 cm;wherein each of the inner pathways extends axially along the length.

In some embodiments, the housing, at at least one of the entry apertureand/or at at least one of the exit aperture, comprises a conicallyshaped protrusion having a rounded external lip.

In some embodiments, the housing comprises a removable or movable coverproviding access to the one or more elongate surgical tools loaded ontothe device and extending along at least a portion of the inner pathways.

In some embodiments, the device is configured to drive movement of aguidewire and a microcatheter, the guidewire configured to at leastpartially extend through a lumen of the microcatheter.

In some embodiments, the device comprises a controller configured tocontrol the plurality of motors for driving the two or more actuationassemblies.

In some embodiments, the controller is controlled remotely by anexternal remote control device.

In some embodiments, there is provided a kit comprising: a device forexample as described herein; a guidewire for loading onto the devicesuch that at least a portion of the guidewire extends along one of theinner pathways; and microcatheter for loading onto the device such thatat least a portion of the microcatheter extends along a second of theinner pathways.

In some embodiments, there is provided a surgical system comprising: arobotic device for example as described herein; and an add-on unit fordriving movement of a guiding catheter, the add-on unit mechanicallyattachable to the housing of the robotic device.

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

Implementation of the method and/or system of embodiments of theinvention can involve performing or completing selected tasks manually,automatically, or a combination thereof. Moreover, according to actualinstrumentation and equipment of embodiments of the method and/or systemof the invention, several selected tasks could be implemented byhardware, by software or by firmware or by a combination thereof usingan operating system.

For example, hardware for performing selected tasks according toembodiments of the invention could be implemented as a chip or acircuit. As software, selected tasks according to embodiments of theinvention could be implemented as a plurality of software instructionsbeing executed by a computer using any suitable operating system. In anexemplary embodiment of the invention, one or more tasks according toexemplary embodiments of method and/or system as described herein areperformed by a data processor, such as a computing platform forexecuting a plurality of instructions. Optionally, the data processorincludes a volatile memory for storing instructions and/or data and/or anon-volatile storage, for example, a magnetic hard-disk and/or removablemedia, for storing instructions and/or data. Optionally, a networkconnection is provided as well. A display and/or a user input devicesuch as a keyboard or mouse are optionally provided as well.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

Some embodiments of the invention are herein described, by way ofexample only, with reference to the accompanying drawings. With specificreference now to the drawings in detail, it is stressed that theparticulars shown are by way of example and for purposes of illustrativediscussion of embodiments of the invention. In this regard, thedescription taken with the drawings makes apparent to those skilled inthe art how embodiments of the invention may be practiced.

In the drawings:

FIG. 1 shows a schematic diagram of a medical system comprising aninsertion device secured to a subject's body, according to someembodiments;

FIGS. 2A-2B illustrate schematic perspective views (front and rear,respectively), of an insertion device, according to some embodiments;

FIGS. 3A-3B illustrate schematic perspective views of an insertiondevice, according to some embodiments;

FIGS. 4A-4B show schematic perspective cross-sectional views of theinsertion device shown in FIGS. 3A-3B, according to some embodiments;

FIG. 5 illustrates a schematic perspective top view of movement controlunits of an insertion device, according to some embodiments;

FIG. 6A illustrates a schematic perspective view of an insertion device,according to some embodiments;

FIG. 6B shows a perspective view of a movement control unit, accordingto some embodiments;

FIG. 6C shows a side view of a movement control element, according tosome embodiments;

FIG. 7 shows a longitudinal cross section view of a movement controlelement of FIG. 6C;

FIG. 8 schematically illustrates a movement control unit, according tosome embodiments;

FIGS. 9A-9B illustrate moving units for linear advancement and/orrotational movement of a medical instrument, according to someembodiments. FIG. 9A shows schematically a piezoelectric actuatedmechanism for linear translation of a medical tool, according to someembodiments, and FIG. 9B shows schematically a piezoelectric actuatedmechanism for rotating a medical tool, according to some embodiments;

FIG. 10 depicts schematic illustrations of an exemplary device capableof imparting both linear and rotational motion on a medical tool,according to some embodiments;

FIG. 11 illustrates a movement control unit, according to someembodiments.

FIG. 12 illustrates an assembly of movement control units, forcontrolling movement of more than one medical instrument, according tosome embodiments;

FIG. 13 is a block diagram of a surgical robotic system, according tosome embodiments;

FIG. 14 is a flowchart of a general method of using a surgical roboticdevice, according to some embodiments;

FIG. 15 is a flowchart of a method of loading a plurality of surgicaltools onto the surgical robotic device, according to some embodiments;

FIGS. 16A-D are various configurations of a remote control device of thesurgical robotic system, according to some embodiments;

FIG. 17 is a schematic example of a screen interface associated with thesurgical robotic system, according to some embodiments;

FIGS. 18A-B are different views of a robotic device, according to someembodiments;

FIGS. 19A-B schematically illustrates a surgical robotic deviceincluding or attached to a guiding catheter driving unit, according tosome embodiments;

FIGS. 20A-C are an example of an isolated mechanism of the guidingcatheter driving unit, an example of a guiding catheter driving unithousing, and a guiding catheter driving unit assembled onto the roboticsurgical system, according to some embodiments;

FIG. 21A-C show mechanisms for actuating rotation (roll) and/or linearmovement of a tool actuated by the robotic surgical system, according tosome embodiments;

FIG. 22 shows an exemplary arrangement of mechanisms driving movement ofa guidewire, according to some embodiments;

FIGS. 23A-B are a schematic diagram and a flowchart pertaining tocontrolling a length and/or position of a tool by adjusting a curvedportion of the tool, according to some embodiments;

FIG. 24 shows a system configuration defining an arrangement of tools inwhich a tool length can be adjusted, according to some embodiments;

FIG. 25 schematically illustrates tool-movement driving mechanisms ofthe system, according to some embodiments;

FIGS. 26A-B are examples of a device configuration including elasticelements (e.g. springs) for selectively engaging tools received by thesystem, according to some embodiments;

FIG. 27 is a schematic block diagram of a robotic device configured formanipulating two or more elongate surgical tools, according to someembodiments;

FIG. 28 schematically illustrates a robotic device for manipulation of aguidewire and a microcatheter, the guidewire extending at least in partwithin the microcatheter lumen, according to some embodiments; and

FIG. 29 schematically illustrates a robotic device for manipulation ofthree or more elongate surgical tools configured for a telescopicarrangement, according to some embodiments.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The present invention, in some embodiments thereof, relates to automatedactuation of elongate surgical tools inserted into a bodily lumen.

A broad aspect of some embodiments relates to a compact robotic devicefor manipulating movement of elongate surgical endoluminal tools whichextend and curve outside of the device housing. Some embodimentsdescribed herein pertain to structural, functional and/or designfeatures suitable for manipulating the tool using a compact sizedrobotic device which dimensions are not affected by the length of thetool being manipulated. In some embodiments, properties of the roboticdevice such as volume, weight are dictated solely by the electrical andmechanical components of the device and substantially not by the toolsbeing manipulated.

An aspect of some embodiments relates to a compact robotic device shapedand sized to be mounted onto a patient's body and/or onto a surgicalbed. In some embodiments, a volume of the device is smaller than 3000cm{circumflex over ( )}3, 2800 cm{circumflex over ( )}3, 2500cm{circumflex over ( )}3, or intermediate, larger or smaller volume. Insome embodiments, a weight of the device is less than 1000 grams, 850grams, 500 grams or intermediate, larger or smaller weight.

In some embodiments, the device comprises a plurality of actuationmechanisms for moving one or more elongate surgical tools (e.g. aguidewire, a microcatheter), for example, for advancing or retractingthe tool linearly, for rolling the tool. In some embodiments, a devicehousing encapsulates the actuation mechanisms, while walls of thehousing define a plurality of entry and/or exit apertures and/oranchoring locations for the tool. In some embodiments, an anchoringlocation (e.g. a holder) at which a proximal end portion of the tool iscoupled to the housing, and an entry aperture for a tool leading to theinner side of the housing are aligned with respect to each other along asimilar horizontal or vertical axis, so that a tool segment extendingbetween the anchoring location and the entry aperture forms a curveexternally to the device housing. In some embodiments, an anchoringlocation and an entry aperture of a tool are defined in a similar face(or wall) of the device housing. In some embodiments, an entry apertureand an exit aperture for the same tool are configured on opposing wallsof the housing, so that a tool entering the housing extends across theinner space defined by the housing, to the exit aperture.

In some embodiments, no device portions protrude outwardly from thehousing, and optionally only the tools loaded onto the device extendoutwardly from the housing.

In some embodiments, a maximal dimension of the robotic device housing(e.g. a width, a height, such as in a box shaped device) is a functionof a distance between exit and entry apertures of a tool that curvesexternally to the device. The distance between the exit and entryapertures may be set, for example, in accordance with a minimal radiusof curvature that the tool can withstand. In an example, a maximaldimension of the device housing is between 2-6 times, 2-10 times, 2-5times or intermediate, higher or lower number of times a minimal radiusof curvature of a tool manipulated by the device and curving outside ofthe housing. A potential advantage of a device housing where a maximaldimension is determined in accordance with a minimal radius of curvatureof a tool that bends upon exiting and re-entering the housing mayinclude providing for a compact, minimalized size housing. In anexample, for a tool having a minimal radius of curvature of X, a minimaldistance between entry and exit apertures of the tool would be 2X. Insuch situation, a wall of the housing through which the tool exits andenters comprises a width of, for example, 2X, 2.1X, 3X, 5X orintermediate, larger or smaller dimension.

In some embodiments, a minimal radius of curvature of an elongate toolincludes a maximal bend of the tool which still allows for the tool tofunction, for example allows the transferring of torque along the lengthof the tool. In some embodiments, a minimal radius of curvature of anelongate tool includes a bend in which the tool remains intact (forexample, not broken).

In some embodiments, exit and entry apertures from and to the housingare shaped to reduce or avoid friction between the tool and the edges ofthe aperture, for example by having a conical profile and/or rounded lipof the aperture. A potential advantage of apertures formed with no sharpedges may include reducing friction contact between the tool and thewalls of the housing, which may reduce a risk of wear or tear of thetool, especially when the tool extends and curves externally to thehousing, before re-entering the housing.

In some embodiments, a shape and/or size of the housing is dictated bythe mechanical and/or electrical components within the housing, forexample, motor(s), motor transmission (e.g. gears), tool actuationmechanisms (e.g. tool-moving elements, such as wheels). In someembodiments, the housing is sized to be as small as possible while stillfully encasing the mechanical components inside it. Optionally, nomechanical components of the robotic device protrude outwardly from thehousing. Optionally, no additional mechanical components from outsidethe housing are required for performing actuation of the tools. In someembodiments, the housing is shaped and configured so that only theelongate surgical tools extend into and out of the housing. In someembodiments, extending out of the housing comprises extending at least 1cm, at least 2 cm, at least 4 cm or intermediate, longer or shorterdistance away from a wall of the housing, such as from a wall throughoutwhich the tool exits the housing. For example, extending of a surgicaltool such as a guidewire or microcatheter at least 1 cm away from thehousing.

In some embodiments, components which are integral to the housing, forexample protrusions which define lips of entry and/or exit apertures ofthe housing, extend out of the housing to a distance of less than 1 cm,less than 0.5 cm, less than 0.3 cm, or intermediate, longer or shorterdistance.

In some embodiments, a housing of the robotic device is not limited to acertain orientation, for example, so that the housing can be positionedin at least a first orientation and in a second orientation, for examplewhere the second orientation is 90 degrees or 180 degrees to the firstorientation. In some embodiments, a symmetry exists so that at least twoopposing faces of the housing are similar in contour and in size,allowing for positioning the device in one of two “flipped”orientations.

In some embodiments, a plurality of pathways are defined through aninner volume of the device, where actuation mechanism(s) for drivingmovement of a tool received within a pathway are configured along thepathway. In some embodiments, a pathway extends between an entryaperture leading into the inner volume of the device housing, and anexit aperture leading out of the inner volume. In some embodiments, theentry and exit apertures are defined on opposing walls of the housing.In some embodiments, the device includes multiple pathways (e.g. 2, 3,4, 6, or intermediate, larger or smaller number of pathways) for receiptof a corresponding number of elongate surgical tools, each tool receivedwithin a pathway. In some embodiments, long axes of pathways areparallel. In some embodiments, actuation mechanisms of multiple pathwaysare aligned side-by-side, and optionally extend along a similar axialextent. In some embodiments, no barrier (e.g. wall, shielding, drape,and the like) exists between actuation mechanisms of the multiplepathways, and the actuation mechanism share a similar space.

An aspect of some embodiments relates to a single-use robotic device formanipulation of elongate surgical tools. In some embodiments, the deviceis disposed (optionally along with the tools manipulated by it)following the surgical procedure. In some embodiments, the single-usedevice does not need to be covered by a sterile drape or cover. In someembodiments, no additional mechanical components are needed to beoperably connected to the single-use robotic device for driving and/ormanipulating tools loaded within the device. In some embodiments, thedevice is provided packaged and pre-sterilized, optionally with one ormore pre-loaded tools. Additionally or alternatively, tools are loadedonto the device in the surgical room.

In some embodiments, a tool that is loaded onto the device comes indirect operable contact with one or more tool-moving elements thatmanipulate it. In some embodiments, one or more tool-moving elements arein direct operable contact with the one or more motors. In someembodiments, the one or more motors and the one of more tool-movingelements are encased in a single housing, and the housing, together withits content, are disposed when the clinical procedure is completed.

In some embodiments, components of the robotic device such as the tooldriving assemblies, and optionally the robotic device as a whole, aredisposed following use along with the tools which were manipulated bythe device. A potential advantage of a disposable device may includethat the tools manipulated by the device are allowed to come into directcontact and/or exist in a similar shared volume with device components,including movement driving components such as motors and/or transmissiongears. In some embodiments, no bordering element or barrier existsbetween the tool and its moving elements and/or driving motors withinthe housing. This is enabled, in some embodiments, due to that thedevice is disposed following use, therefore risk of contamination whichmay occur, for example, upon re-use, is avoided. Some potentialadvantages of a device in which the loaded tool may contact the device'stool-moving elements (and/or other device components, e.g. motors)directly may include simplifying use, potentially reducing loading time,and potentially improving the mechanical engagement with the tool (forexample since no “bordering” elements are needed), thereby reducing oravoiding unwanted tool movements such as slippage, twisting, or kinkingof the tool.

In some embodiments, no sterile barriers are required between the deviceactuation components and the tools manipulated by the device. In somecases, existence of the tools and device actuation components in a sameshared volume may imply that during operation, fluid (e.g. blood,saline) contacted by and/or flowing within the tool may also come incontact with the device actuation components, yet a risk ofcontamination would be reduced or prevented since the device is suppliedin a sterile state and does not require cleaning or re-sterilizationfollowing its use.

In some embodiments, the device is constructed from durable,lightweight, disposable and optionally recyclable materials, such asplastic, aluminum, steel, copper, and/or other suitable metals.

An aspect of some embodiments relates to a dual-function assembly inwhich both linear movement and rotational movement (e.g. roll) of anelongate tool are carried out at a same physical location. In someembodiments, the assembly is configured for linearly moving the toolwhile the tool is being rolled; or vice versa—rolling the tool while thetool is being moved linearly.

In some embodiments, the assembly comprises an elongate shaft with acentral lumen in which the tool is received. A set of wheels arepositioned adjacent the shaft and each of the wheels at least partiallyextends into the central lumen to operably contact the tool inside. Insome embodiments, a motor which drives rotation of the wheels is mountedadjacent the wheels, for example, under the shaft. In some embodiments,rotation of the wheels pushes or retracts the tool, depending on thedirection of rotation. In some embodiments, the motor which drivesrotation of the wheels is configured as a part of the assembly.Alternatively, driving force is transferred to the wheels via motortransmission.

In some embodiments, the inner walls of the shaft, which define thecentral lumen, are contoured to match an outer contour of at least someof the wheels. In such construction, the central lumen extends into aspace in between the wheels, feeding the tool into close contact withthe wheels. In an example, in a 4-wheel assembly, the inner walls of theshaft may be contoured to match at least one, two, three or all four ofthe wheels, at the central lumen segment which is closest to a contactpoint where the tool contacts the wheel(s).

In some embodiments, a gear that is co-axial with the shaft is connectedalong the shaft and/or at a proximal or distal end of the shaft, so thatupon rotation of the gear, the shaft and wheel set are rotated by thegear as a single unit, thereby rolling the tool (e.g. guidewire,steerable microcatheter) that is within the central lumen of the shaft.

A potential advantage of an assembly which drives linear and rotationalmovement of a tool at a same physical location (such as a specificphysical location within the device housing and/or a specific locationof engagement with the tool) may include reducing or avoiding unwantedtool movement such as slippage, kinking, twisting which may occur forexample if two spaced apart mechanisms were to each drive linearmovement and rotational movement respectively, and the tool would needto extend in between—where the unwanted movement may occur. Anotherpotential advantage is the compact design enabled by assigning twofunctions, such as rotation and advancement/retraction of the tool, tothe same site.

An aspect of some embodiments relates to driving rotation (roll) of anelongate tool, at two spaced apart engagement locations along the lengthof the tool, using the same motor. In some embodiments, the tool isengaged by elements which rotate the tool at two or more points alongthe length of the tool, for example, at a proximal portion of the tool(e.g. adjacent a handle of the tool), and at a more distal portion. Inan exemplary construction, a first gear rotates a holder which holds aproximal portion of the tool; rotation of the first gear then rotates asecond gear which is a part of the linear movement assembly (such asdescribed herein), where the second gear rotates a shaft in which a moredistal portion of the tool is received. In such arrangement, actuationof a single motor drives rotation of both the first and second gears,generating rotation (roll) of the tool at both engagement locations.

A potential advantage of driving rotational movement at two spaced apartengagement locations along the length of the tool using a single motormay include improved control over the tool, for example as compared touse of two different motors for driving rotation at the two locations,where actuation timing and/or speed and/or direction of the two motorswould need to be synchronized to ensure uniform roll of the tool alongits length.

In some embodiments, one or more tools which are manipulated by thedevice are engaged and manipulated only from their proximal portion(e.g. from a tool handle); while one or more additional tools areengaged at a more distal segment thereof (i.e. not from the toolhandle).

An aspect of some embodiments relates to controlling a usable length ofan elongate surgical tool by modifying a size of a curve of the tooloutside of the robotic device. In some embodiments, a tool manipulatedby the device extends in a curved manner (bends) outside of the housingone or more times. In some embodiments, when a length of a more distalsegment (e.g. a tool segment extending between an exit aperture from thedevice housing and a target within the patient's body) changes, thecurve is expanded or contracted in size. In some embodiments, a toolpasses into and out from the device housing several times, forming morethan one curve outside the housing. For example, a guidewire is curvedtwice—once independently, optionally between a proximal handle and amore distal portion, and a second time while being received within alumen of a curved microcatheter. In some embodiments, the curve is a “U”shaped curve, which can be modified, for example, by lengthening orshortening a distance of a maximal point of the “U” shape relative tothe closest wall of the device housing.

The invention, in accordance with some embodiments, relates to automateddevices for inserting an elongate surgical medical tool into a bodilylumen, and more specifically to body-mountable automated devices forinserting elongate surgical medical tools, such as guidewires andmicrocatheters into blood vessels.

Many medical procedures, such as catheterization for diagnostic and/ortherapeutic purposes, require insertion of a catheter into the patient'sblood vessels and other body lumens.

Typically, the physician first inserts a guidewire into an artery, suchas the femoral artery, or a vein, and navigates it through the torturousvasculature until it reaches the target, which may be the heart, anartery, a peripheral blood vessel, the brain etc. Once properlypositioned, the physician places a catheter over the guidewire, andpushes the catheter until it too reaches the target. In some cases, theprocedure requires use of a small radius catheter, typically known as amicrocatheter. In such cases, the physician may insert the microcatheterdirectly, without use of a guidewire. Manual insertion and navigation ofguidewires/microcatheters through the torturous vasculature is not onlychallenging for the physician, but it may also be hazardous to thepatient, as even subtle erroneous movements may result in unintentionalperforation of the blood vessel wall. Further, manual procedures requirethe physician and additional medical personnel to be present at theprocedure room during the entire procedure. Since most invasiveprocedures are done under imaging, such as X-ray, CT, etc., the medicalpersonnel, as well as the patient, are exposed to radiation.

Remotely manipulated automated (robotic) devices have been developed inrecent years, however, existing robotic devices are cumbersome andexpensive. Therefore, there is a need for a small, inexpensive and easyto use automated device for inserting guidewires and/or microcathetersinto bodily lumens, such as blood vessels, and navigating therethroughto a target region.

According to some embodiments, the insertion device may include a powersource. In some embodiments, the power source may be a battery, a powersupply, and the like. In some embodiments, the battery is disposable. Insome embodiments, the battery is reusable. In some embodiments, thebattery is rechargeable. In some embodiments, the power supply may bedirectly or indirectly connected to mains power. In some embodiments,insertion device may include one or more printed circuit boards (PCBs),configured to relay/process/convey instructions and/or electricalconnection between various components of the device.

According to some embodiments, the insertion device may allow the linearand/or rotational advancement/movement of the medical instrument. Insome embodiments, the insertion device may be configured toautomatically advance the insertion device and/or further automaticallyallow the rotational movement thereof by rotating the insertion device.In some embodiments, when the medical tool is a guidewire, the insertiondevice may allow controlling the linear and/or rotation and/or tipparameters of the guidewire. In some embodiments, when the medical toolis a guidewire, the insertion device may allow automatically and/orremotely controlling the linear and/or rotation and/or tip parameters ofthe guidewire. In some embodiments, the medical instrument may bepreloaded onto the medical device, prior to being used for a medicalprocedure. In some embodiments, the medical instrument may be preloadedonto the medical device, prior to being placed on the subject's body.

According to some embodiments, there is provided an insertion deviceconfigured to remotely and automatically linearly advance one or moremedical tools (such as a guidewire and catheter) into and within bodilylumens, such as blood vessels, for endovascular procedures, includingcoronary, peripheral and cerebral endovascular procedures. In someembodiments, the insertion device is configured to further automaticallyand/or remotely control/allow the rotational movement of the one or moremedical tools. In some embodiments, the insertion device is furtherconfigured to control parameters of the one or more medical tools, suchas, tip stiffness. In some embodiments, the device is configured tocontrol a force applied by a distal tip of the tool, for example bycontrolling one or more of: speed of advancement of the tool, astiffness of the tool. Optionally, the tool is manipulated such that itsdistal tip applies a constant force or a varying force onto structuresencountered by the tip (e.g. tissue such as a vessel wall).

According to some embodiments, there is provided an insertion deviceconfigured to remotely and automatically linearly advance one or moremedical tools (such as a guidewire and catheter) into and within bodilylumens, for various endoluminal procedures. According to someembodiments, when the first tool is a guide wire and the second medicaltool is a catheter, the insertion device may allow the linear,rotational and/or tip parameters control of the guidewire, and thelinear motion (over the guidewire) of the catheter, and rotation motionthereof (relative to the insertion device).

According to some embodiments, the linear velocity of advancement of themedical instrument may be in the range of about 0-100 mm/sec or anysubranges thereof. In some exemplary embodiments, the linear velocity ofthe medical instrument may be in the range of about 0-50 mm/sec, 1-100mm/sec, 5-50 mm/sec or intermediate, higher or lower velocity. Thevelocity may be constant and/or in varying increments and may beadjusted (manually and/or automatically), during the procedure. In someembodiments, the velocity may be in the range of about 0-25 mm/sec withincrements of about 0.1 mm/sec. In some embodiments, the velocity may bein the range of about 25-50 mm/sec with increments of about 1 mm/sec. Insome embodiments, the position holding stability at actuator is about0.1 mm. According to some embodiments, the rotational movement may be inanywhere in the range of 360 degrees.

According to some embodiments, the rotational movement may be continuousin the range of 360 degrees. In some embodiments, the number of fullrevolutions may be limited. In some embodiments, the number of fullrevolutions may be limited to about 5-10 revolutions in each directionfrom the neutral (starting) setting.

According to some embodiments, the rotation position resolution may bein increments of 1-5, 0.5-10 degrees, 0.1-1 degrees or intermediate,higher or lower resolution. In some exemplary embodiments, therotational position resolution may be about +/−2 degrees, +/−1 degree,+/−0.5 degrees or intermediate, higher or lower resolution.

According to some embodiments, the controller of the device may be aremote controller. In some embodiments, the controller of the device maybe integrated with the device. In some embodiments, the controller ofthe device may be connected by wired or wireless means. In someembodiments, the controller may be configured to allow control over theoperation of the medical device. In some embodiments, the controller maybe configured to allow control of advancement of the medical instrument,including, but not limited to: linear direction of advancement, velocityof advancement, increment of advancement, rotational movement, degree ofrotational movement, and the like or any combination thereof. In someembodiments, the controller may include one or more operating buttons.In some embodiments, the buttons may include pressure buttons, sliderbuttons, joystick, and the like, or any combination thereof. In someembodiments the system may have means for injecting a contrast agentinto the lumen, e.g., the vasculature. The injection mechanism may beremotely operated, so as to allow the surgeon/physician to perform theentire procedure from a remote location. In some embodiments, the systemmay be configured to control linear and/or rotational movements of aguiding catheter, if used in the procedure.

As referred to herein, a “robotic device” or “device” may refer to thedevice housing inclusive of mechanical and/or electrical componentsaccommodated inside the housing. In some embodiments, the “device” isnot meant to cover add-ons or external components such as a guidingcatheter driving unit (when coupled externally to the housing and notintegrated in it), a mounting of the device, a remote control of thedevice, and the like.

As referred to herein, an “assembly” or “actuation assembly” may includetool-moving elements, such as wheels, and/or a coupling for the tool,such as an elongate shaft in which the tool is received. In someembodiments, an “assembly” or “actuation assembly” further comprises oneor more motors and/or transmission (e.g. gears) which transfer forcefrom one or more motors external to the assembly.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth in the following description and/orillustrated in the drawings and/or the Examples. The invention iscapable of other embodiments or of being practiced or carried out invarious ways.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details set forth in the following description orexemplified by the Examples. The invention is capable of otherembodiments or of being practiced or carried out in various ways.

Reference is made to FIG. 1, which shows a schematic diagram of anexemplary medical system, according to some embodiments. As illustratedin FIG. 1, system 2 includes a body-mountable miniature automatedinsertion device 4, configured to insert a medical instrument, such as aguidewire 6, into a subject's 8 lumen (such as, a blood vessel).According to some embodiments, depending on the location of the targettissue (for example, the heart, a peripheral blood vessel in the lowerextremities, brain, liver, and the like) and the purpose of theprocedure, the entry point may be selected from, but not limited to, atthe patient's groin (i.e., the femoral artery), arm (i.e., the radialartery) or neck (i.e., the jugular vein). Accordingly, the location ofthe insertion device 4 on the patient's body may vary. In the exampleshown in FIG. 1, the device is attached to the patient's thigh, to allowaccess to the patient's femoral artery. It can be appreciated that thedevice may additionally or alternatively be attached to the patient'sarm, or any other desired location on the patient's body, depending onthe selected entry point. According to some embodiments, the device maybe attached/mounted/secured to the patient's body using any suitableattachment element. For example, the device may be attached to thepatient's body using a band, which can be pulled over the patient's legup to his/her thigh. The band may be flexible, such that it stretchesaccording to the circumference of the thigh, or it may be substantiallyrigid or semi-flexible and include a length-adjusting mechanism.Alternatively, one or more straps may be wrapped around the patient'sthigh directly. Such straps may be substantially rigid or semi-flexible,having a length-adjusting mechanism, and provided with connectors (e.g.,buckles) at their opposite ends, for fastening the straps and securingthem to the patient's thigh. The bands/straps may include one or moresensors, such as force sensor, disposed thereon.

According to some embodiments, the insertion device is not bodymountable, but configured for positioning in close proximity to thepatient's body, e.g., using a robotic arm, a base structure configuredfor securing to the patient's bed, etc.

In some embodiments, the insertion device may be disposable, eitherpartially, such that some of its components are discarded and replacedbetween procedures, or entirely, such that the entire insertion deviceis disposed of once the procedure has been completed, i.e., a single-usedevice. In other embodiments, the insertion device may be reusable, suchthat it can be used repeatedly with new medical instruments (e.g.,guidewires and/or catheters).

In some embodiments, the device may be configured such that it can beused to insert into bodily lumens a variety of different medicalinstruments, of varying lengths and diameters, including, for example,guidewire, catheter, microcatheters, and the like. In some exemplaryembodiments, without limitation, the device may be adapted to insertinto a blood vessel, a guidewire such as that disclosed in co-owned U.S.Pat. No. 9,586,029, titled “Guidewire Having Selectively AdjustableStiffness and Tip Curvature”, and/or in co-owned U.S. Patent ApplicationPublication No. US 2018/214,675, titled “Double Concentric Guidewire”,both to Shekalim et al, and incorporated herein by reference in theirentireties.

According to some embodiments, the system may further include acontroller 10 for controlling the operation of the device, inparticular, the insertion and/or steering of the medical instrument/s(such as, a guidewire and/or a catheter) toward the target (e.g., heartchamber, blocked artery, etc.). The controller 10 may be coupled to theinsertion device 4 via a wired connection or a wireless connection, andit may be either manually operated by a physician (for example, thecontroller may be in a form of a joystick), or automatically operatedusing a dedicated software. In the latter case, the system may furthercomprise a computer 12, which may include at least one processor, userinterface and a display. The computer 12 may be a personal computer(PC), a laptop, a tablet, a smartphone or any other processor-baseddevice. In some embodiments, the controller 10 is disposable. In someembodiments, the controller 10 is reusable. In some embodiments, thecontroller 10 is configured to interact/couple to more than oneinsertion device.

In some embodiments, the system 2 may further include an imaging device,or it may be used in conjunction with an imaging device. The utilizedimaging modality may be any one of X-ray fluoroscopy, CT, cone beam CT,CT fluoroscopy, MRI, ultrasound, or any other suitable imaging modality.According to some embodiments, the insertion device may be capable ofadvancing the medical instrument linearly within the bodily lumen. Insome embodiments, the device may further be capable of rotating themedical instrument within the lumen alternatively or in addition tolinearly advancing the medical instrument. In some embodiments, thedevice may further be capable of rotating the medical instrument withinthe vessel separately and/or also simultaneously, while linearlyadvancing the medical instrument. For example, in some exemplaryembodiments, the insertion device may be capable of advancing aguidewire and/or catheter linearly within the blood vessel. In someembodiments, the device may further be capable of rotating a guidewireand/or catheter within the vessel alternatively or in addition tolinearly advancing the guidewire and/or catheter. In some embodiments,the device may further be capable of rotating a guidewire and/orcatheter within the vessel separately and/or also simultaneously, whilelinearly advancing the guidewire and/or catheter. According to someembodiments, as further exemplified herein, the insertion device isconfigured to allow the linear advancement of the medical instrumentwithin the bodily lumen along with the rotational movement thereof, byutilizing one or more actuators that further advantageously enable thesmooth movement of the medical instrument, without deforming the medicalinstrument (i.e., without forming tension or twists along the length ofthe medical instrument). According to some embodiments, as furtherexemplified herein, the linear and rotational movements of the medicalinstrument (such as a guidewire and/or microcatheter) may be generatedby separate actuators, or by one or more dual-purpose actuators,configured to allow both rotational and linear movement of theinstrument/s.

Reference is now made to FIGS. 2A-2B, which illustrate schematicperspective views (front and rear, respectively), of an insertiondevice, according to some embodiments. As shown in FIG. 2A, insertiondevice includes elements for advancing a first medical instrument (shownas guidewire 22), in a linear direction and optionally in rotationaldirection (as indicated by the movement arrows). As illustrated in FIG.2A, the proximal end of the guidewire 22 may be secured to a dedicatedholder 34, that may further allow control over tip parameters of theguidewire 22, as described below. The guidewire 22 advances from a firstopening 35 in the holder (on the front face of the device 20), to enterthe insertion device 20 via a second opening 36, and re-exit the device20 from a different opening (first rear opening (not shown)) at the rear(back) face of the device 20. The guidewire 22 can then re-enter theinsertion device 20 through another opening (second rear opening (notshown)) at the rear face of the device 20, and can re-exit the insertiondevice 20 from a third (front) opening 37, such that the distal end 24of the guidewire 22 after exiting the third opening 37 can be configuredto be inserted into a body of a subject, more particularly to a bodilylumen, such as a blood vessel.

In some embodiments, as illustrated in FIG. 2A, the guidewire 22 exitsthe insertion device 20 into the lumen of a second medical instrument(shown as catheter 32), which can be connected/attached/associated withthe first rear opening, re-enter the insertion device 20 via the secondrear opening and exit the front face of the insertion device 20 via thethird front opening 37. In some embodiments, the second medicalinstrument is configured to be inserted into the bodily lumen. In someembodiments, the second medical instrument (such as, catheter 32) may beinserted into the bodily lumen together with and/or following theadvancing of the first medical instrument (e.g., guidewire 22) by theautomated medical device 20. The above-described winding path of theguidewire 22 and/or the catheter 32 enables a compact spatialarrangement (e.g., side by side) of the movement control units(described below), thus minimizing the device's overall size. In someembodiments, pathways (e.g. shafts) through which the tools extendinside the housing are aligned side by side, and are optionally parallelto each other. A lateral alignment in which the movement actuationmechanisms are positioned substantially side by side may provide for asmaller device size, such as a thinner device width.

The small size of the device allows, in some embodiments, positioning ofthe device on the subject's body.

In some embodiments, the medical device 20 includes one or moreactuators/elements configured to allow the linear and/or rotationmovement/advancement of the medical instrument/s. In some embodiments,as illustrated in FIG. 2A, device 20 includes a first movement controlunit 26 configured to allow linear and/or rotational movement of theguidewire 22. The first movement control unit 26 may include one or moreactuators/motors allowing the movement of the guidewire 22, as furtherdetailed herein below. Device 20 may further include a second movementcontrol unit 28) configured to allow linear and/or rotational movementof the catheter 32. The second movement control unit 32 may include oneor more actuators/motors allowing the movement of the catheter 32, asfurther detailed herein below.

Optionally, device 20 may further include at least one additionalmovement control unit, for example, in instances in which the guidewireis comprised of a hollow outer wire and an inner wire disposed within alumen of the outer wire, as disclosed, for example, in abovementionedU.S. Patent Application Publication No. US 2018/214,675. In suchinstances, an additional movement control unit 29 may be used to allowthe controlling of the movement of the inner wire of the guidewire 22relative to the outer wire of the guidewire 22, to control tipparameters of the guidewire 22, such as stiffness and/or curvature. Themovement of the inner wire relative to the outer wire may be achieved bymeans of an adjuster/slider 33 attached to the inner wire, anon-rotating nut 30 and a lead screw 31 threaded therein. Rotation ofthe screw 31 by a motor/actuator causes linear movement of the nut 30along the length of the lead screw 31, which in turn causes linearmovement of the adjuster/slider 33 and the inner wire attached thereto.In some embodiments, the movement control unit 29 may allow one or moreof the following relative states between the inner and outer wires ofthe guidewire 22: 1) the distal tip of the inner wire extends distallybeyond the distal tip of the outer wire, 2) the distal tip of the innerwire is translated proximally such that it resides within the outer wire(i.e., the distal tip of the outer wire extends beyond the distal tip ofthe inner wire, and/or 3) the distal tips of the inner and outer wiresare aligned. In some embodiments, rotation of the guidewire 22 and theholder 34 to which it is attached, at its proximal end, may becontrolled by the movement control unit 26. In some embodiments, inorder to ensure that the holder 34 smoothly rotates together withguidewire 22, so as to prevent twisting/kinking of the guidewire 22 (asthe guidewire 22 may not be able to rotate relative to the holder 34),the movement control unit 29 may include an additional actuator/motor,e.g., coupled to the proximal end of the holder 34, to further controlthe rotation of the holder 34.

Reference is now made to FIG. 2B, which shows a perspective rear view ofinsertion device 20. As shown in FIG. 2B, insertion device 20, includeselements/units for advancing a first medical instrument (shown asguidewire 22), in a linear direction and optionally in rotationaldirection (as indicated by the movement arrows). As illustrated in FIG.2B, the proximal end of the guidewire 22 may be secured to a dedicatedholder 34. The guidewire 22 may advance from the first opening 35 in theholder 34 (on the front face of the device), to enter the insertiondevice 20 via a second opening (not shown in FIG. 2B), and re-exit thedevice 20 from a first rear opening 38 at the rear (back) face of thedevice 20. The guidewire 22 may then re-enter the insertion device 20through a second rear opening 39 at the rear face of the device 20, andthen re-exit the insertion device 20 from a third (front) opening (notshown in FIG. 2B), such that the distal end 24 of the guidewire 22,after exiting the third opening, may be configured to be inserted into abody of a subject, more particularly to a bodily lumen, such as a bloodvessel.

In some embodiments, as illustrated in FIG. 2B, the guidewire 22 mayexit the insertion device 20 from the first rear opening 38 into thelumen of a second another medical instrument (shown as catheter 32),which may be connected/attached/associate with the first rear opening38, re-enter the insertion device 20 via the second rear opening 39 andexit the front face of the insertion device 20 via the third frontopening. In some embodiments, the second medical instrument 32 isconfigured to be inserted into the bodily lumen. In some embodiments,the second medical instrument (such as, catheter 32) may be insertedinto the bodily lumen together with and/or following the advancing ofthe first medical instrument (e.g., guidewire 22) by the automatedmedical device.

Reference is now made to FIGS. 3A-3B, which illustrate schematicperspective top views, of an insertion device, according to someembodiments. As shown in FIG. 3A, insertion device 50 includes a casing52 and a top cover 53, which is shown in an open configuration. Furthershown is a holder 54 which holds the proximal end of the guidewire 58and may further allow, in some embodiments, to adjust the tip parametersof the guidewire 58. In some embodiments, the top cover 53 is intendedto allow access 14 to the holder 54, such that the holder 54, with theguidewire 58 attached thereto, may be inserted into and/or removed fromthe casing 52. As shown in FIG. 3A, the guidewire 58 may advance from afirst front opening 55 in the holder 54, to enter the casing 52 via asecond front opening 56, and re-exit the casing 52 from a first rearopening (not shown)) at the rear face of the casing. The guidewire 58can then re-enter the casing through a second rear opening (not shown)on the rear face of the casing 52, and re-exit the casing 52 from athird front opening 57. In some embodiments, as illustrated in FIG. 3A,the guidewire 58 exits the first rear opening of the casing 52, whilebeing threaded within the lumen of another medical instrument (shown ascatheter 62), which may be connected/attached/associated with the firstrear opening, re-enter the casing 52 via the second rear opening andexit the front face of the casing 52 via the third front opening 57. Insome embodiments, the second medical instrument 62 is configured to beinserted into the bodily lumen. In some embodiments, the second medicalinstrument (such as, catheter 62) may be inserted into the bodily lumentogether with and/or following the advancing of the first medicalinstrument (e.g., guidewire 58) by the automated medical device, i.e.the guidewire 58 may serve as a rail on which the catheter 62 rides.

The above-described winding path of the guidewire 58 and/or the catheter62 enables a compact spatial arrangement of the movement control unitsof the device 50, as described below, thus minimizing the device'soverall size. The small size of the device allows, in some embodiments,positioning of the device 50 on the subject's body. In some embodiments,the medical device includes one or more actuators/elements/unitsconfigured to allow the linear and/or rotation movement/advancement ofthe first and second medical instruments.

Reference is made to FIG. 3B, which schematically illustrates themedical device of FIG. 3A, with the top cover 53 and a top portion ofthe casing 52 removed. As illustrated in FIG. 3B, the device 50 mayinclude a first movement control unit 66 configured to allow linearand/or rotational movement of the guidewire 58. The device 50 mayfurther include a second movement control unit 68, configured to allowlinear and/or rotational movement of the catheter. The first movementcontrol unit 66 and the second movement control unit 68 may include oneor more: actuators/motors, gears, racks shafts, rotational screws,allowing the movement (linear and/or rotational) of the guidewire and/orcatheter, respectively, as further detailed herein below. In someembodiments, the device 50 may include one or more additional movementcontrol units. For example, in instances in which the guidewire issecured at its proximal end to a holder 54, the device 50 may furtherinclude a movement control unit having at least a motor/actuator and agear 65 which control the rotation of the holder 54 about its axis.

As shown in FIG. 3B, in instances wherein the guidewire 58 includes ahollow outer wire and an inner wire disposed within the lumen of theouter wire, the device may include an additional movement control unitcomprised of a non-rotating nut 63 attached to an adjuster/slider 61 ofthe holder, which is rigidly attached to the proximal end of the innerwire, and a lead screw (not shown) threaded within the nut 63, to allowthe controlling of the movement of the inner wire relative to the outerwire, thus controlling the tip parameters of the guidewire (such as,adjusting the stiffness and/or curvature thereof). Rotation of the leadscrew by a motor/actuator (not shown) causes linear movement of the nut63 along the length of the lead screw, which in turn causes linearmovement of the adjuster/slider 61 and the inner wire attached thereto.

In some embodiments, one or more of the following relative statesbetween the inner and outer wires of the guidewire may be enabled by theabove movement control unit: 1) the distal tip of the inner wireextending distally beyond the distal tip of the outer wire, 2) thedistal tip of the inner wire being translated proximally so as to bedisposed within the outer wire (i.e., the distal tip of the outer wireextending beyond the distal tip of the inner wire, and/or 3) the distaltips of the inner and outer wires being aligned.

Reference is now made to FIGS. 4A-4B, which show perspective views ofcross sections of the insertion device of FIGS. 3A-3B, according to someembodiments. Shown in FIG. 4A, is a longitudinal cross-section view ofinsertion device 50 (illustrated in FIGS. 3A-3B), cross sectioned at aline between the first movement control unit (66 in FIG. 3B), and thesecond movement control unit (68 in FIG. 3B). As shown in FIG. 4A, thefirst movement control unit 66 includes at least one motor (shown asmotor 75), a shaft 76, through which the first medical instrument (shownas guidewire 58) is moved. Also shown are gears (such as exemplary gear78). In addition, movement element 80 is indicated. As furtherelaborated below, movement element 80 includes at least two opposinground discs/wheels/rings placed one above the other and/or placed onadjacent the other and having a space therebetween, such that themedical instrument (shown as guidewire 58) is located in this space.

Further shown in FIG. 4A is the rear end opening 82, through which theguidewire 58 can exit the device, for example into a catheter lumen,which is configured to be connected to the rear end opening. Referenceis now made to FIG. 4B, which illustrates a longitudinal cross sectionof the first movement control unit 66.

As shown in FIG. 4B, the movement element 80 includes two opposingspinning wheels/discs/rings (86A, 86B), placed one over the other and/orone adjacent the other, with a space therebetween. In the space formedbetween the wheels, guidewire 58 is located, such that upon spinning ofthe wheels (which is actuated, for example, by various interconnectedgears), linear movement of the guidewire 58 within the shaft 76 towardsthe rear opening 82 is facilitated. By controlling the velocity of thespinning, the velocity of advancement of the guidewire 58 may becontrolled. In some embodiments, the movement control unit 66 and/or themovement element 80 may be rotated along a longitudinal axis, therebyfurther allowing the rotational movement of the guidewire 58. In someembodiments, the wheels may be similar or different in size, shape,stiffness, material or composition.

As can be further observed in FIGS. 4A-B, in some embodiments, anaperture through which a tool passes into and/or out of the housing isstructured to reduce friction between the tool and the walls of thehousing. For example, aperture 81 (through which guidewire 48 re-entersthe housing) defines a conically shaped protrusion ending with a roundedlip. A potential advantage of an aperture of the housing being formedwith a rounded shape and no sharp corners may include reducing frictionbetween the tool and the walls of the housing, thereby potentiallyreducing a risk of tear or wear of the tool (e.g. due to the toolrubbing against the wall). This may be especially advantage for devicessuch as described herein, in which the tool extends and curves outsideof the housing, and may therefore be more prone to touching the aperturewalls, for example as compared to tool which is held solely along asingle straight linear axis.

Reference is now made to FIG. 5, which illustrates a schematicperspective top view of movement control units of an exemplary insertiondevice, according to some embodiments. As shown in FIG. 5, insertiondevice 100, includes several movement control units. A first movementcontrol unit 110 is configured to allow advancement of the guidewire108, which is inserted therethrough after having been re-inserted intothe insertion device (as detailed above). A second movement control unit120 is configured to allow advancing of a second medical tool (such as acatheter) after the guidewire 108 has re-entered the insertion device,while being threaded within the lumen of the second medical tool(catheter), via a second rear opening, towards the front face of theinsertion device (via a corresponding front opening), as detailed above.A third, optional, movement control unit 102 is configured to allowcontrolling the rotation of the holder 104, in instances in which aholder 104 is used for holding the proximal end of the 30 guidewire 108,depending on the type of guidewire being used, so as to preventtwisting/kinking/tangling of the guidewire 108 while the guidewire isbeing rotated.

As shown in FIG. 5, the first movement control unit 110 may include achannel/shaft 113, through which the guidewire 108 is passed, and amovement element 114. Further shown are a motor 111) and one or moregears (representative gear 112 is shown), which allow controlling theoperation of the movement control unit 110. The movement element 114 mayinclude a rotating disc/ring/wheel 115, which is positioned so as to bein contact with the guidewire 108, whereupon spinning/rotation thereof,the guidewire 108 may linearly advance along its route. The guidewire108 may be pushed toward the rotating disc/ring/wheel 115 by means of aspring/screw preloaded pinion. In some embodiments, the guidewire ispushed to the rotating disc/ring/wheel 115 by means of a pair ofspring/screw preloaded pinions.

As shown in FIG. 5, facing the wheel 115 may be a groove, which forms abent in the guidewire 108. The built-in bent in the guidewire's pathincreases the perpendicular distance of the line of action of force fromthe axis of rotation, which would be equal to the radius of theguidewire if the guidewire were to follow a linear path, thus enablingto exert a sufficient rotating moment (torque) on the thin guidewire,without having to apply a high normal force on the guidewire.

As further shown in FIG. 5, the channel/shaft 113 may have anopening/slit 116 along its length, to allow access to the guidewire 108and further to allow placement/removal of the guidewire 108, if need be.In some embodiments, the first movement control unit 110 may rotateabout an axis (for example, by the control of actuators 118), therebyallowing the rotational movement of the guidewire 108 (and the holder104). In instances where rotational movement is actuated, the opening113 may accordingly face another direction.

As further shown in FIG. 5, the second movement control unit 120includes at least a channel 123, through which the medical instrument(s)are passed, and a movement element 124. Movement element 124 may includea rotating disc/ring/wheel 125, which is in contact with the medicalinstrument (e.g., the catheter with the guidewire threaded therein)placed in the channel 123, whereupon rotation thereof, the medicalinstrument can advance along its route.

As shown in FIG. 5, the channel 123 may have an opening/slit 126 alongits length, to allow access to the medical instrument and further allowplacement/removal of the medical instrument, if need be. In someembodiments, the second movement control unit 120 may be configured torotate about its axis, thereby allowing the rotational movement of thesecond medical instrument (e.g., the catheter).

As further shown in FIG. 5, the third, optional, movement control unit102 may include at least one gear 130, allowing the rotation of theholder 104. In some embodiments, in which the guidewire 108 comprises adouble concentric guidewire (i.e., an inner wire disposed within thelumen of an outer hollow wire), the device 100 may further includeactuators/element to allow controlling of the relative movement betweenthe inner and outer wires of the guidewire, so as to control parametersof the tip of the guidewire (for example, the stiffness and/or curvatureof the guidewire). in some embodiments, the device may include anon-rotating nut 103 attached to an adjuster/slider of the holder 104,which is rigidly attached to the proximal end of the inner wire, and alead screw 105 threaded within the nut 103, to allow the controlling ofthe movement of the inner wire relative to the outer wire, thuscontrolling the tip parameters of the guidewire (such as, adjusting thestiffness and/or curvature thereof). Rotation of the lead screw 105causes linear movement of the nut 103 along the length of the lead screw105, which in turn causes linear movement of the adjuster/slider and theinner wire attached thereto.

In some embodiments, one or more of the following relative statesbetween the inner and outer wires of the guidewire may be enabled by theabove movement mechanism: 1) the distal tip of the inner wire extendingdistally beyond the distal tip of the outer wire, 2) the distal tip ofthe inner wire being translated proximally so as to be disposed withinthe outer wire (i.e., the distal tip of the outer wire extending beyondthe 20 distal tip of the inner wire), and/or 3) the distal tips of theinner and outer wires being aligned.

Reference is now made to FIG. 6A, which illustrates a schematicperspective view of an exemplary insertion device, according to someembodiments. As shown in FIG. 6A, the insertion device 150 may include ahousing (shown as semi-transparent housing 158) which encases movementcontrol units 156 configured for advancing a medical instrument (such asa guidewire 154), in a linear direction and, optionally, in rotationalmovement. As illustrated in FIG. 6A, the proximal end of the guidewire154 may be secured to a dedicated holder 152 that may further allowcontrol over tip parameters of the guidewire 154. The guidewire 154 canadvance from the holder 152 to enter the insertion device via anopening, and re-exit the device from a different opening at the oppositeface of the device. In some embodiments, the guidewire 154 may exit theinsertion device 150 into the lumen of another medical instrument (suchas a catheter), which can be connected/attached/associated with anopening of the device.

Reference is now made to FIG. 6B, which shows a perspective view of themovement control unit 156. As shown in FIG. 6B, the movement controlunit 156 may include a shaft/channel 162, through which the medical tool(such as guidewire 154) can pass/advance. Movement control unit 156further includes a medical instrument linear drive (168) and optionallya rotational drive (164). The movement control unit 156 may furtherinclude a slip ring 160 configured to allow rotational movement. Themovement control unit 156 may further include one or morerotating/spinning elements (such as wheels and gears), configured tomediate mechanical movement of various moving parts, as detailed below.Reference is now made to FIG. 6C, which shows a side view of themovement control unit 156. Shown in FIG. 6C is shaft 162, guide wire154, rotational drive 164, as well as slip ring 160.

Reference is now made to FIG. 7, which shows a longitudinal crosssection view of the linear drive 168 of the movement control unit shownin FIG. 6C, essentially along the center of shaft 162.

As shown in FIG. 7, the linear drive 168 may include at least tworings/wheels/discs (170A, 170B), placed/situated/located one above theother and having a limited space therebetween. The medical instrument(such as guide wire 154) is configured to pass via the tight spacebetween wheels 170A and 170B, such that upon spinning/rotation of thewheels, the guidewire, which is at least partially in contact with bothwheels, advances linearly.

In some embodiments, the wheels/rings/discs 170A and 170B may beidentical in size, shape, composition, or form. In some embodiments, thewheels/rings/discs 170A and 170B may be different in size, shape,composition, stiffness, material or form. In some embodiments, the spacebetween the wheels 170A and 170B is formed in a groove, such that themedical instrument 154 is slightly bent, to allow better rotation of themedical instrument. A potential advantage of a built-in bent in theguidewire's path may include increasing the perpendicular distance ofthe line of action of force from the axis of rotation (which would beequal to the radius of the guidewire if the guidewire were to follow alinear path), thus enabling to exert a sufficient rotating moment(torque) on the thin guidewire, without having to apply a high normalforce on the guidewire.

Reference is now made to FIG. 8, which schematically illustrates amovement control unit, according to some embodiments. As shown in FIG.8, movement control unit is configured to allow linear advancementand/or rotational movement of a medical instrument (such as a guidewire202). In some embodiments, the medical instrument 202 can advance alonga path, for example, as defined by a channel or shaft (shown as channel204). In order to allow linear movement of the medical instrument 202,the movement control unit may comprise a linear drive element 200, whichmay include two or more spinning/rotating elements, shown in FIG. 8 aswheels/discs/rings 206A and 206B.

As shown in FIG. 8, the wheels may be placed side by side, forming atight space therebetween. The medical instrument 202 me be threadedbetween the wheels, such that it may pass below a first wheel 206A andabove a second wheel 206B, so as to form an S shape, or substantially anS shape. By this manner, since the medical instrument 202 is at leastpartially in contact with the wheels, spinning/rotation of the wheels inopposite directions causes the instrument 202 to linearly advance. Therelative spinning direction of the wheels 206A and 206B can determinethe direction of the linear movement of the medical instrument 202.

In some embodiments, the movement control unit may further include arotational drive element 210, which can allow rotation (for example, indirection 212) of the linear drive element 200 and hence of the medicalinstrument 202 intertwined therein. By utilizing the intertwining of themedical instrument around the wheels in an S shaped path as detailedabove, the medical instrument can rotate freely around its axis, withoutslippage and without forming bents along its length. In someembodiments, the movement control unit is located/placed on a platform(shown as platform 214), to allow free rotation of the unit.

Reference is now made to FIGS. 9A-9B, which illustrate moving units forlinear advancement and/or rotational movement of the medical instrument,according to some embodiments. In some embodiments, as shown in FIG.9A-9B, linear and/or rotational movement of the guidewire may begenerated by means of piezoelectric actuators. Piezoelectric elementsare composed of ceramic material which changes its geometric dimensionsas a function of the applied voltage. Piezoelectric elements enableactivation at high frequencies, e.g., 50-150 kHz, and they can producerelatively large forces, which are linearly correlated to the degree oflengthening of the element (stroke). Using piezoelectric actuators in anautomated medical device is advantageous as their activation does notgenerate a magnetic field, which is undesirable in medical applications.Further, piezoelectric actuators are MRI compatible. In someembodiments, other actuator types may be used, for example,electromagnetic actuators (solenoid), DC motors, stepper motors or ACmotors.

According to some embodiments, the insertion device may include twoseparate portions/units; a first portion for generating linear movement(also referred to hereinafter as “linear portion”) and a second portionfor generating rotational movement (also referred to hereinafter as“rotational portion”), to allow each movement type, i.e., linear androtational, to be generated independently of the other. A combinedmovement, i.e., simultaneous rotation and linear advancement, may begenerated by activating the two portions in an ordered or alternatemanner.

In some embodiments, the linear portion may be in the form of aninchworm motor, and it may comprise three piezoelectric actuators, asshown in FIG. 9A. Piezo actuators 301 and 303 are used to grip themedical instrument 304 (e.g., a guidewire), by extending (lengthening)and relaxing (shortening) along the vertical axis when powered, andmotion is achieved by piezo actuator 302 lengthening and shorteningalong the horizontal axis when powered. In some embodiments, piezoactuator 301 and/or 303, may include a single actuator which presses theguidewire 304 against a static element, when extending, to grip theguidewire 304. In other embodiments, piezo actuators 301 and/or 303 arede facto a pair of piezo actuators, positioned on opposite sides of theguidewire 304, such that both extend and relax to grip and release,respectively, the guidewire 304. The actuation process of the linearportion is a cyclic process. In order to move the instrument 304 fromleft to right, for example, piezo actuator 303, which is the forwardclutch piezo in this example, is first extended so as to grip theinstrument, as shown in FIG. 9A. Next, piezo actuator 302, the lateralpiezo, is extended, resulting in piezo actuator 1003, together with theinstrument, moving a small distance to the right. It should be notedthat the center of piezo actuator 302 is fixated, such that when poweris supplied to piezo actuator 302, its extension is symmetrical to bothsides, left and right. Since at this stage of the process piezo actuator301, which is the aft clutch piezo in this example, is in a relaxedstate, and does not grip the instrument, the instrument, which isgripped by piezo actuator 303, moves to the right. Next, piezo actuator301 is extended so as to grip the instrument, followed by the relaxationof piezo actuator 303, so as to release its grip of the instrument.Next, piezo actuator 302 is relaxed. Next, piezo actuator 303 isextended to re-grip the instrument, followed by the relaxation of piezoactuator 301.

As shown in FIG. 9B, the rotational portion/moving unit of the devicemay include a pair of piezo actuators 306, 307, which contact theinstrument 308 on opposite sides, parallel to one another. Extending thetwo piezo actuators in opposite directions 309A and 309B causes theinstrument to rotate. In some embodiments, at least one of the clutchpiezo actuators/pairs, i.e., piezo actuator 301 and/or piezo actuator303, may be part of the rotational portion of the device, as well as ofthe linear portion of the device, as described above. In otherembodiments, an additional pair of piezo actuators may be used forrotating the guidewire.

Reference is now made to FIG. 10, depicting a schematic illustration ofan exemplary device capable of imparting both linear and rotationalmotion on a medical tool, according to some embodiments. In someembodiments, the linear motion may be achieved in an inchworm mannerusing piezo motors 401, 402 and 403, essentially as described above withrespect of FIGS. 9A-9B, but with additional piezo motors 404 and 405serving as clutches which are moved toward and away from the medicaltool (shown as guidewire 408) by piezo motor 403. In order to rotate theguidewire clockwise (“CW”), for example, piezo motor 403 isrelaxed/contracted, such that it moves piezo motors 404 and 405 towardthe guidewire 408, until they grip the guidewire, at opposite sides.Piezo motor 405 is then extended (moved downward), while piezo motor 404is simultaneously relaxed/contracted (moved upward), causing theguidewire to rotate. Piezo motor 401 is then extended, so as to grip theguidewire, and piezo motor 403 is extended, so as to release the grip ofthe guidewire by moving piezo motors 404 and 405 away from theguidewire, to their original position. In alternative embodiments, anadditional piezo motor may be coupled to one of piezo motors 404 and405, instead of piezo motor 403, to move it toward and away from theguidewire. In such embodiments, rotation of the guidewire may beachieved by both piezo motors 404 and 405 extending (or contracting), inopposite directions. The utilized piezo actuator/s may be, for example,the PICMA® Monolithic Multilayer PZT Actuator, manufactured by PICeramic GmbH, Germany. In some embodiments, the rotating piezo actuatorscan rotate the entire linear advancement assembly.

Reference is now made to FIG. 11, which illustrates a movement controlunit having two concentric circular components, which can rotate onerelative to the other, according to some embodiments. As shown in FIG.11, movement control unit 500 includes a first movement control element502 (such as a piezoelectric motor) configured to allow linear motion(advancement) of a medical instrument (such as guidewire 510), in anylinear desired direction 505. The first movement control element 502 isfixed to the inner concentric circular component 530 (see also FIG. 12).Movement control unit 500 further includes a second movement controlelement 504 configured to allow rotational motion of the first movementcontrol element 502 by rotating the inner concentric circular component,in any desired clockwise or counter-clockwise direction 507.

Further shown in FIG. 11 is an optional setting, in which the proximalend of the medical instrument is secured to a dedicated holder 520. Insome embodiments, for example when the guidewire comprises a doubleconcentric guidewire (i.e., an inner wire disposed within the lumen ofan outer hollow wire), the holder may include a mechanism which allowscontrolling parameters of the medical instrument, such as tip stiffness,which includes at least an adjuster/slider 503 configured to linearlymove the inner wire relative to the outer wire. Further, an additionalmovement control unit 506 may be present, which allows control over therotation of the holder 520 with the instrument attached thereto.

Reference is now made to FIG. 12, which illustrates an assembly ofmovement control units, for controlling movement of more than onemedical instrument, according to some embodiments. As shown in FIG. 12,movement control assembly 600, includes two separate moving controlunits 602 and 604 that may be utilized in conjugation, such that eachunit is configured to allow actuating and controlling movement of adifferent medical instrument.

As shown in FIG. 12, a first movement control unit 602 includes variousmoving elements, allowing linear motion (advancement) and/or rotationalmotion of a first medical instrument (such as guidewire 610),essentially as detailed above with respect of FIG. 11. A second movementcontrol unit 604, includes various moving elements, allowing linearmotion (advancement) and/or rotational motion of second medicalinstrument (such as microcatheter 612). In some embodiments, themovement (linear and/or rotational) of the first medical instrument 610may be independent of the movement (linear and/or rotational) of thesecond medical instrument 612.

In some embodiments, the movement (linear and/or rotational) of thefirst and second medical instrument may be synchronized. In someexemplary embodiments, as illustrated in FIG. 12, the first medicalinstrument (for example, a guidewire) may pass and advance through thelumen of the second medical instrument (for example, a catheter).According to some embodiments, any suitable actuator type may be used inany of the movement control units, devices and systems disclosed herein,including, but not limited to: motors (such as, DC motors, AC motors,stepper motors, and the like), electromagnetic actuators (solenoid),piezoelectric actuators, pneumatic actuators, hydraulic actuators, andthe like.

FIG. 13 is a block diagram of a surgical robotic system, according tosome embodiments.

In some embodiments, a robotic system 1301 is suitable for use in asurgical room. Optionally, one or more system components (such ascontrolling components, imaging components) are physically separate fromthe rest of the system and may be used remotely.

In some embodiments, system 1301 is configured to receive one or moresurgical tools (e.g. a guidewire, a microcatheter, a guiding catheter,an intermediate catheter, and/or other elongate surgical tool) and toactuate movement of the tools.

In some embodiments, the system is configured to drive linear movement(e.g. advancement and/or retraction) of a tool received therein, and/ordrive rotational movement (e.g. axial rotation) of a tool receivedtherein. In some embodiments, linear and rotational movements areactuated simultaneously.

In some embodiments, system 1301 includes a robotic device 1303 fordriving movement of one or more tools. In some embodiments, the devicehousing accommodates and/or is operably connected to one or more of thefollowing components:

-   -   one or more actuators such as one or more motors 1305, and        optionally associated transmission of the motors.    -   Tool moving elements 1317, such as wheels, configured to        operably contact a tool received by the system to move the tool        (e.g. advance, retract, rotate the tool). In some embodiments,        the tool moving elements are driven directly (e.g. by        contacting) or indirectly (e.g. via one or more gears or other        transmission) by the motors 1305. Optionally, only some tool        moving elements are driven (directly or indirectly) by motors,        while other tool moving elements move in response to movement of        the tool and/or in response movement of a motor-driven tool        moving element.    -   a controller 1307, configured to receive and/or send operation        signals to and/or from a general control unit 1309. General        control unit 1309 may be configured as a remote control device,        a console, a control unit physically attached to the system        base, or a combination thereof. In some embodiments, the        controller 1307 is configured to coordinate manipulation (e.g.        linear movement, rotation) of tools received and operated by the        robotic system.    -   powering means 1311, including for example a battery and/or        connection means for mains electricity.    -   sensing means 1315, for example, one or more sensors configured        for detecting, for example, whether a tool has been inserted; a        relative position of the tool; a position of tool-moving        elements (e.g. wheels); actual movement of the tool-moving        elements (e.g. by a counter counting the number of wheel        rotations); sensors for communicating with other system sensors,        and/or for other measurements and/or indications. In some        embodiments, sensors are configured for detecting motor status,        for example, a motor position, a motor rotation rate. Sensors of        various types may be used, such as optical sensors, pressure        sensors, force measurement sensors, speed sensors, sensor for        detecting electrical current, flow sensors, position sensors        (e.g. optical, magnetic, electrical position sensors).    -   a memory 1313, which stores, for example, parameters related to        tool movement, such as speed of movement, rotation, translation,        angulation, deflection angle; indications obtained by one or        more system sensors, such as a measure of force acting on the        tool, stiffness of the tool; parameters related to the patient        body and sensed by the inserted tools (e.g. heart rate, blood        pressure, temperature, oxygenation level, and/or other sensed        parameters).

In some embodiments, the robotic device (also referred to herein as aninsertion device) is compact and is small enough in dimensions so as toreduce interference to surgical room personnel (e.g. nurse, surgeon)and/or to surgical room equipment and/or to the patient. In someembodiments, the device footprint is smaller than 500 cm{circumflex over( )}2, 250 cm{circumflex over ( )}2, 180 cm{circumflex over ( )}2 orintermediate, larger or smaller area. In some embodiments, a volume ofthe device is less than 3500 cm{circumflex over ( )}3, 2800cm{circumflex over ( )}3, 2000 cm{circumflex over ( )}3 or intermediate,larger or smaller volume. In some embodiments, a weight of the device isless than 1.5 kg, less than 1 Kg, less than 800 grams, less than 500grams or intermediate, higher or lower weight.

In some embodiments, the robotic device is substantially block shaped,for example having a box shaped compact configuration. Otherconfigurations may include a cylindrical configuration, a rounded (e.g.ball shaped) configuration, a saddle shape, and/or other.

In some embodiments, system 1301 includes an integrated imaging modality319. Alternatively, the system is configured to be operably attached to(for example, communicate with) an existing imaging modality. An imagingmodality may include, for example, X-ray fluoroscopy, CT, cone beam CT,CT fluoroscopy, MRI, ultrasound, or any other suitable imaging modality.

In some embodiments, system 1301 comprises a mounting 1321 for placingdevice 303 relative to the patient and/or relative to the surgical bed.In some embodiments, the mounting comprises or is configured to attachto an adjustable fixture. Optionally, a height and/or angle and/ordistance of the system relative to the patient (e.g. relative to thelocation of body entry) and/or relative to the bed are adjustable.

In some embodiments, system 1301 comprises or is configured to engage anadaptor 1323 for operably engaging a tool's proximal portion, forexample, a handle.

In some embodiments, the adaptor defines a mechanical engagement betweenthe one or more motors 1305 and one or more components of the handlewhich move the tool. For example, the adaptor connects one or moremotor(s) or associated transmission with a slider component of thehandle which deflects the tool tip upon sliding; with a knob componentof the handle which rolls the tool when rotated; and/or with otherhandle components. Additionally or alternatively, the adaptor itselfincludes one or more integrated motors for driving movement of thehandle components.

FIG. 14 is a flowchart of a general method of using a surgical roboticdevice, according to some embodiments.

In some embodiments, a decision is made, for example by a physician,surgeon and/or other clinical personnel, to operate (1401). In someembodiments, the operation is for therapeutic purposes. Additionally oralternatively, the operation is for diagnostic purposes.

In some embodiments, the operation involves catheterization. In someembodiments, the operation involves insertion of one or more tools intoand/or through vasculature and/or into other non-vascular endoluminalstructures. Examples of tools may include: a guide wire, amicrocatheter, a rapid exchange catheter, a guiding catheter, a ballooncatheter, a stent or coil, ablation tools, an intermediate catheter, asuction catheter, an ultrasound catheter, a pressure catheter and/orother tools. In some embodiments, the operation is a through-lumen basedprocedure. In some embodiments, the operation is an over-the-wire basedprocedure.

In some embodiments, the device is positioned relative to the patient(1403). In some embodiments, the device is mounted onto the surgicalbed, for example via a fixation. In some embodiments, the device isattached to the patient, for example mounted onto the patient's leg(e.g. to the thigh), to the patient's arm, and/or to other body parts.Attachment of the device to the surgical bed and/or to the patient maybe carried out using straps, bands, a rigid mounting, and/or otherattachment means.

In some embodiments, attachment to the bed is carried out using a standwhich is stabilized relative to mattress and/or to the rail of the bedand/or to the floor. The system can then be mounted on the stand, forexample attached via a snap fit mechanism, magnetic means, straps (e.g.Velcro), and/or other. In some embodiments, the stand is adjustable soas to enable use with patients of various sizes and/or different bedheight and the like. In some embodiments, when setting a position of thedevice, one or more of a height, entry angle to the body, alignment ofthe device relative to the patient are selected. The device position maybe defined with respect to the patient body or parts thereof (e.g.relative to the surgical entry point) and/or relative to the surgicalbed and/or relative to other surgical room equipment, e.g. relative toimaging modules.

A potential advantage of attaching the device to the patient's body, forexample to a limb and/or other body portion (e.g. leg, arm (optionallythe snuffbox of the hand), neck, foot, etc.) may include that the devicecan be positioned closer to the entry opening into the body. In suchconfiguration, a length of a tool segment extending between the deviceand the body may be reduced, potentially allowing for more efficient useof a tool's length. In some embodiments, the device is compact enough soas to fit on top of a patient's limb, for example, without protrudinglaterally from the limb when the device is attached onto the limb (forexample, the device is sized not to extend laterally from a patient'sthigh).

In some embodiments, loading of the tools is performed (1405). In someembodiments, loading of tools is performed after the device position(e.g. relative to the patient and/or to the bed) is set; alternatively,loading of tools is performed before the device position is set.Optionally, one or more tools are preloaded onto the device, and areoptionally provided along with the device. In an example, the device isprovided in a sterilized package while already being loaded with one ormore tools. Additionally or alternatively, tools are unwrapped in thesurgical room and are loaded onto the device, for example by a nurse,technician and/or other clinical personnel. In some embodiments, toolsare loaded and/or replaced during operation, for example when switchingfrom a navigational tool (e.g. a guidewire) to a treating tool, such asan embolization tool, a catheter balloon, and/or other treating tool.

In some embodiments, the device is constructed so that no shielding(e.g. no physical separation by a wall, a wrap, a drape) exists or isrequired between the tool-moving element and the tool being loaded, forexample, such that direct contact is formed between the tool and thetool-moving elements (e.g. wheels, gears, and/or other actuators).Optionally, no draping by a sterile drape or other cover is required.For example, in a single-use device that is disposed following surgery,due to having no permanent components, there is no need to cover thedevice and/or specific components of it which contact the tools by asterile drape. A potential advantage of a device in which the device isconfigured to engage the surgical tools directly, without a separationor cover may include a simpler, more efficient, time and/or costeffective preparation process and/or cleaning process following surgery.

Alternatively, in some embodiments, the device (and/or selectedcomponents of the device, such as the tool moving elements) are at leastpartially covered by a sterile drape or sheath.

In some embodiments, operation is performed by controlling, via a userinterface of the device, movement of the surgical tools received withinthe units (1407). Exemplary manipulation of tools controlled by thedevice may include: linear advancement and/or retraction of a tool;rotation of a tool (e.g. roll about the tool axis); twisting of a tool;angular orientation of a tool (e.g. by curving a distal tip of a tool);articulation (e.g. of a distal tip of a tool); changing of mechanicalproperties of a tool, such as stiffness, for example by controlling,from a proximal end of the tool, a distal tip structure or innerarrangement.

In some embodiments, manipulation of tools is performed remotely.Optionally, the surgeon operates the system from a different room.Alternatively, the surgeon stays in the surgical room, and may operatethe system while being adjacent or far from the bed.

In some embodiments, manipulation of tools involves maneuvering of toolsthat are attached to each other and/or inserted into one another and/orotherwise assembled in a manner in which movement of one tool may affectthe other, for example, when a guidewire extends within a lumen of amicrocatheter. In such situation, controlling movement may involvecarrying out (via user control and/or automatically by the system, uponidentification of movement) “compensation” movements of the guidewireand/or microcatheter with respect to each other, which may be requiredwhen both are driven together in an assembled configuration (such aswhen the guidewire is within the microcatheter lumen in the position ofthe tool moving elements of the unit, where the tool is manipulated). Inan example, when the microcatheter is advanced or retracted, it may bedesired to hold the guidewire in place without having the guidewire movealong with the microcatheter. This may be carried out, for example, bydriving the linear movement mechanisms of both tools, but in oppositedirections (e.g. advancing the microcatheter distally while at the sametime driving the guidewire mechanism in a manner that would retract theguidewire proximally). A potential advantage of synchronized controlledmovement of tools that are used together (such as a guidewire extendingwithin a lumen of a microcatheter) may include the ability to hold onetool while advancing the other tool, for example by driving theactuation mechanisms of the tools in opposite directions—one tool wouldbe advanced or retracted while the other tool would effectively remainin place.

In some embodiments, the user interface is configured on the deviceitself (e.g. as a screen and/or buttons and/or a joystick attached tothe system units and/or to the base), and/or on a separate physicianconsole, and/or on a separate remote control device. Control signals maybe communicated via wired and/or wireless communication (e.g. networkbased communication) to the device.

In some embodiments, the device (e.g. the device controller) isprogrammed to include a loading mode, for insertion and/or calibrationof tools and/or of the device motors; and an operational mode, wheremovement of the tools is carried out.

In some embodiments, the device or specific components of it aredisposed following operation (1409). Optionally, the device is disposedas a whole, optionally including the tools loaded on it.

FIG. 15 is a flowchart of a method of loading a plurality of surgicaltools onto the surgical robotic device, according to some embodiments.

In some embodiments, a robotic device for example as described herein isprovided (1501). In some embodiments, one or more elongate surgicaltools such as a guidewire, a microcatheter, a guiding catheter, a rapidexchange catheter and/or other surgical tools are provided (1503).

In some embodiments, a proximal handle of a tool such as a guidewire isplaced in engagement with a designated adaptor or holder (1505), forexample as described in co-filed PCT titled “ROBOTIC MANIPULATION OF ASURGICAL TOOL HANDLE” (Attorney Docket No. 83117) which is incorporatedherein by reference.

In some embodiments, the guidewire is threaded (such as from the distalend direction) into a designated shaft of the guidewire drivingmechanism of the robotic device (1507). Then, at least a portion of theguidewire length which exits the shaft (existing the device housing) isthreaded into a lumen of a microcatheter (1509).

In some embodiments, a proximal end of the microcatheter (which has notyet been physically attached to the device) is secured to the device atan exit port of the guidewire from the housing (1511). Then, at least aportion of the microcatheter length (including the guidewire receivedinside) is threaded into a designated shaft of the microcatheter drivingmechanism of the device (1513). The microcatheter is then passed (alongwith the guidewire received inside) through a lumen of a guidingcatheter (1515).

Optionally, the guiding catheter is received or engaged by a guidingcatheter driving mechanism, which may be externally operably coupled tothe device housing or, alternatively, integrated inside the device.

Then, in some embodiments, the one or more tools are introduced into thepatient's body (1517) and are manipulated using the device.

In an exemplary use, the robotic device is loaded with a guidewire andoptionally a microcatheter. Optionally, a guiding catheter (a distalportion thereof) is manually inserted into the patient's body. Then, therobotic device is placed adjacent a proximal end of the guidingcatheter, and the guiding catheter (optionally along with amicrocatheter in which the guidewire is received) is inserted into thelumen of the guiding catheter. In some embodiments, insertion into theguiding catheter lumen is performed via a seal element, which may be anintegrated part of the robotic device or, alternatively, separate fromit. Then, in some embodiments, the user connects the proximal end of theguiding catheter to the robotic device. From this point on, manipulation(e.g. linear advancement/retraction, and/or rotation) of the guidewireand/or of the microcatheter inside the lumen of the guiding catheter andoptionally upon the guidewire and/or microcatheter exiting the guidingcatheter (such as into a lumen of a vessel) may be carried outrobotically using the device (for example, through a remote controlinterface). In some embodiments, linear advancement and/or retraction ofthe guiding catheter, for example to a certain limited extent, is alsocarried out using the robotic device.

FIGS. 16A-D are various configurations of a remote control device of thesurgical robotic system, according to some embodiments.

In some embodiments, the remote control device is shaped to be manuallyheld by a user, e.g. a physician. Optionally, the remote control deviceis lightweight and small enough to be held by the user without blockingthe user's view of visual aids such as a screen showing the results ofimaging during operation. In some embodiments, the remote control deviceincludes one or more portions shaped to be gripped by the user palmand/or engaged by the user's fingers.

In some embodiments, the remote control device communicates with themodular robotic system. In some embodiments, the communication iswireless, performed for example via wi-fi, infrared, Bluetooth, RF,and/or other wireless modules.

In some embodiments, the remote control device includes or is incommunication with a controller of the modular robotic system. In someembodiments, maneuvering of tools received by the system is performedvia the remote control device. Examples of tool movements and/or otheroperational manipulations of the tools which are controlled by theremote control device may include: linear advancement and/or retractionof a tool; axial rotation of a tool; control of a tool distal tip; speedof movement; control of unique tool functions (e.g. inflation/deflationof a balloon in a balloon catheter, stent deployment and/oradvancement), and/or other tool manipulation.

Other functions which may be controlled via the remote control deviceinclude, for example: automated injection of materials (e.g. contrastagents, washing solutions) into and through a tool lumen; linear and/orangular movement of the assembled system as a whole (e.g. sliding of theassembled system relative to a mounting); safety stop of the system;on/off actuation of the system; supply of electrical power to the systemor to specific components; and/or other system functions.

FIGS. 16A-B show a first example of a remote control device 1601, andFIGS. 16C-D show a second example of a remote control device 1603. Insome embodiments, the device includes interfaces in the form of one ormore of: push buttons 1605, joystick handles 1607, manual sliders 1609,rotating knobs, 1611 and the like.

In some embodiments, the remote control device comprises a screen, suchas for notifying a user regarding current controls and/or for receivingcommands from the user.

In some embodiments, the remote control device includes an interface(e.g. a button) for rapid retraction of tools. Such interface may beused in case of an emergency, device failure, or the like and/or forplanned retraction of a tool, such as for replacing the tool with a newtool.

In some embodiments, the remote control device is modular. Optionally,specific buttons and/or add-on interfaces are selectively attached(and/or are uncovered to enable their use). For example, buttons forcontrolling movement of a guiding catheter (when a guiding catheterreceiving unit has been attached on the system) are exposed for use onlywhen required (e.g. are positioned under a removable or movable cover).In another example, an interface for controlling injection of materialsthrough one or more system junctions is attached to the remote controldevice and/or uncovered for use upon need.

The remote control device may be operated at a distance from the system.Optionally, the remote control device is operated by a surgeon locatedin a different room. Optionally, the remote control device is operatedby a surgeon located in the surgery room (adjacent the bed or at adistance from the bed).

In some embodiments, the remote control may be configured as a screeninterface, for example for use in a cell phone, tablet, computer or thelike, such as described below.

FIG. 17 is a schematic example of a screen interface associated with thesurgical robotic system, according to some embodiments.

In some embodiments, additionally or alternatively to a remote controldevice for example as described hereinabove, a screen interface 1701 incommunication with the system may be used. In some embodiments, thescreen interface is configured for receiving data (such as from thedevice and/or from imaging means and/or from the physician and/or from ahospital system), presenting data, sending and/or receiving commands toand from the robotic device, and/or other.

In some embodiments, the screen interface may be configured in acomputer, a laptop, a tablet, as a cell phone application and/or other.

The user interface screen shown in this figure presents examples offunctions and/or indications related to operation of the tools by therobotic device, including, but not limited to: tool movement type (e.g.guidewire roll, guidewire advancement/retraction, microcatheteradvancement/retraction, guiding catheter roll, guiding catheteradvancement/retraction); guidewire tip control (e.g. guidewire tipdeflection); tool speed and/or movement direction (e.g. increasing thespeed using “turbo” mode, initiating fast or partially fast retraction);emergency stop (in case of device failure, medical emergency situationor the like; in some embodiments, the emergency stop button stops powersupply to the robotic device); controlling movement of two (or more)tools together; customized control of tool movement, such as: control ofaccessories including devices and/or add-on accessories used with thesystem and/or tools, such as: injection of material through a port;inflation of a balloon; stent expansion; tip curvature, tool stiffness.

FIGS. 18A-B are different views of a robotic device, according to someembodiments.

In some embodiments, a robotic device 1801 is shaped and sized to belocated adjacent the patient (e.g. attached to the bed) and/or locatedon the patient, for example on a patient's limb (e.g. on the patient'sthigh). In the example shown, device 1801 comprises a compact housing1802 having a saddle shaped bottom portion 1803. Optionally, the saddleshaped portion is shaped and sized to be seated on a patient's limb, ona rail of the bed, on a designated mounting (e.g. a mounting having aplanar bottom for positioning on a planar surface, not shown), and/orother. In some embodiments, a second portion 1805 of the housing extendsfrom the saddle bottom, the second portion accommodating the one or moretool driving mechanisms.

In some embodiments, a guidewire is loaded onto the device 1801 asfollows: in some embodiments, a proximal portion (e.g. a handle) of theguidewire is received within an accessible compartment 1807, optionallycovered by a lid 1809 (compartment 1807 may also be referred to hereinas an “adaptor” or “holder”). Optionally, manipulation of one or moreguidewire handle components is performed within compartment 1807 by oneor more movers which engage the handle (e.g. engage a slide of thehandle, a rotational knob of the handle, and/or other handlecomponents).

In some embodiments, a more distal portion of the guidewire (adjacentthe handle) exits compartment 1807 via aperture 1813. Then, in someembodiments, an even more distal portion of the guidewire (optionally,the distal most end of the guidewire) is then inserted through an entryaperture 1811 into the device housing, where the inserted guidewire isreceived within a designated shaft (not shown) of its driving mechanism.In some embodiments, the guidewire exits the housing again, optionallyfrom an opposite wall of the housing, via aperture 1815. In someembodiments, a location of aperture 1815 also serves as a securing pointfor a proximal end of a microcatheter. Optionally, the microcatheter isthreaded on a knob 1817 and/or other suitable protrusion to be securedto the housing. When the guidewire exits through aperture 1815, it isreceived within a lumen of the microcatheter.

In some embodiments, the microcatheter (along with the guidewireextending inside) is curved (e.g. to a “U” shape) outside the housing tobe inserted, via an aperture 1819, into a designated shaft of themicrocatheter driving mechanism. The microcatheter (along with theguidewire inside) then exits the housing on an opposite wall, viaaperture 1820.

In some embodiments, the device housing is shaped and sized solely foraccommodating the tool driving mechanisms, without being affected bytool size considerations, such as tool length, a tool width (e.g.diameter). Optionally, the housing protects the tool driving mechanisminside while only the tools themselves remain visible and/or contactableexternally to the housing. Optionally, no driving mechanisms arevisible. A potential advantage of such construction may include reducinga risk of damage (e.g. by unwanted contact) with the tool drivingmechanisms.

In some embodiments, a portion of a tool that extends within the housingitself is less than 25%, less than 20%, less than 10%, less than 5% orintermediate, larger or smaller percentage of the total length of thetool. A potential advantage of a housing which accommodates the drivingmechanisms and does not require a long portion of a tool to be receivedinside may include allowing for a relatively compact housing havingsmall dimensions and/or small weight.

In some embodiments, the housing includes a removable or movable portionsuch as a lid. Optionally, the lid is opened in case of an emergencyand/or robot malfunction, for example to manually release the tools.Alternatively, the lid is opened in case of a need to replace the tools.

In some embodiments, opening of the lid automatically returns the devicemotors to an initial (home) position and/or orientation. Optionally, theactuation mechanisms of the tools, for example a designated shaft inwhich a tool is received, are rotated to be aligned such that a slotextending along the shaft faces upwards, in the direction of the openlid. A potential advantage of the motors and/or tool shafts beingautomatically aligned upon opening of the lid of the device housing mayinclude that tools can be more easily approached for adjustment and/orremoval of a tool from its mechanism.

Exemplary dimensions of upper portion 1805 of the device (without thesaddle shaped bottom, which could alternatively be formed as a planarsurface) may include: an axial length 1821 of less than 12 cm, a width1823 of less than 7 cm, a height 1825 of less than 9 cm.

In some embodiments, housing 1802 is formed of a relatively lightweightyet durable material, such as plastic, aluminum, composite materials.Optionally, the material is recyclable, so that a disposed device (e.g.a single use device) may be at least partially recycled.

FIGS. 19A-B schematically illustrates a surgical robotic deviceincluding or attached to a guiding catheter driving unit, according tosome embodiments.

FIGS. 19A-B show robotic devices having different shaped housings. FIG.19A shows a robotic device housing 1900 such as described above in FIGS.18A-B, seated on a mounting 1921 which defines a planar surface. FIG.19B shows a substantially box shaped housing 1902, having a square orrectangular cross section profile.

In some embodiments, a guiding catheter driving mechanism 1901 isconfigured as a separate add-on unit configured to operably couple tothe robotic device, for example, to be appended to device housing 1903.

In some embodiments, the guiding catheter driving unit attaches to thehousing in a manner in which a microcatheter existing the housing (suchas via an aperture 1905) enters a lumen of a guiding catheter loadedonto the guiding catheter unit. In some embodiments, attachment of theguiding catheter unit to the housing is by one or more of: aninterference fit coupling (e.g. via respective protrusions andindentations of the device housing and a housing of the guiding catheterdriving unit), a sliding attachment (e.g. including a rail 1906, forexample as shown in FIG. 19A).

In some embodiments, rail 1906 moveably couples the guiding catheterdriving unit 1901 to one or more motors located inside the housing ofthe device, for example so that a motor drives back and forth movementof the unit for moving the guiding catheter. In some embodiments, theguiding catheter driving mechanism is configured to drive linearmovement and/or rotational movement (i.e. roll) of the guiding catheter.In some embodiments, the guiding catheter driving unit is configured toelectrically connect to the robotic device and receive power supply fromit. Alternatively, the guiding catheter driving unit includes anindependent power supply (e.g. a battery).

In some embodiments, the guiding catheter driving unit connects to therobotic device via mechanical connections, such as by a snap fitconnection, an interference fit connection, pin and socket, and/or othersuitable mechanical coupling.

Alternatively, in some embodiments, the guiding catheter drivingmechanism is inside the robotic device housing, and forms an integralpart of the robotic device.

In some embodiments, the guiding catheter driving mechanism isconfigured for driving linear movement of the guiding catheter within aselected distance range, for example, to advance and/or retract thecatheter a distance of 3 cm, 5 cm, 10 cm, or intermediate, longer orshorter distance. In some embodiments, this provides for fine tuning ofa position of a guiding catheter previously inserted into the patient.

In some embodiments, to ensure that a microcatheter within the guidingcatheter moves along with the guiding catheter, the microcatheterdriving mechanism is controlled for compensating for that movement, forexample, the microcatheter is actuated to move in an opposite directionto the guiding catheter. Optionally, a guidewire within themicrocatheter moves along with the microcatheter as a single unit anddoes not require independent actuation.

FIGS. 20A-C are an example of an isolated mechanism of the guidingcatheter driving unit, an example of a guiding catheter driving unithousing, and a guiding catheter driving unit assembled onto the roboticsurgical system, according to some embodiments.

In some embodiments, a guiding catheter mechanism (see FIG. 20A)includes one or more motors, such as a motor 2001 for driving linearmovement, and a motor 2003 for driving rotation. In some embodiments, aproximal portion of the guiding catheter 2005 is attached at connector2009. In some embodiments, in operation, motor 2001 rotates a lead screw2007 which in turn advances or retracts connector 2009, therebyadvancing or retracing the guiding catheter 2005. In some embodiments,motor 2003 moves linearly along with connector 2009.

In some embodiments, activation of motor 2003 rotates connector 2009,thereby rotating (rolling) the guiding catheter 2005.

FIG. 20B is an external view of a guiding catheter unit 2000. In someembodiments, the unit comprises an elongate housing 2011, and the leadscrew 2007 (such as shown in FIG. 20A) extends throughout the housing.In some embodiments, housing comprises one or more ports leading intothe guiding catheter lumen. For example, an injection port 2010 throughwhich materials (e.g. liquid agents, saline, etc.) can be injected intoand through the lumen of the guiding catheter.

In some embodiments, housing 2011 is shaped for attaching to the roboticdevice. In an example, the housing defines an abutment 2012 which canlean against the external housing of the robotic device and/or at leastpartially connect to it, such as by being received within a respectiverecess or indentation defined at the robotic device housing.

FIG. 20C shows the guiding catheter unit 2000 connected to a roboticdevice 2013. In some embodiments, the guiding catheter unit is coupledto an external wall of the device housing 2015. Optionally, the guidingcatheter unit extends distally in the direction of insertion into thepatient.

As further shown in this example: a guidewire 2019 extends from aguidewire holder 2021 and into a designated shaft of the guidewiredriving mechanism; the guidewire then exits the housing at 2025, whichalso serves as a securing point for the microcatheter 2027, and theguidewire enters the microcatheter lumen. Then, the microcatheter isbended to enter the device housing at 2029, being received within adesignated shaft of the microcatheter driving mechanism. When themicrocatheter (along with the guidewire received within) exits thehousing, it is received within a lumen of the guiding catheter 2005 heldand manipulated by the guiding catheter unit 2000.

FIGS. 21A-C show mechanisms for actuating rotation (roll) and/or linearmovement of a tool actuated by the robotic surgical system, according tosome embodiments.

In some embodiments, as shown in the exemplary mechanism of FIG. 21A, aguidewire 2101 inserted into a designated shaft is engaged by at leastone pair of driving wheels 2103 positioned opposite each other andcontacting the guidewire that passes between them. A motor 2105 fordriving linear movement of the tool actuates rotation of the wheelswhich, depending on the rotation direction, cause the guidewire to moveaxially in a proximal or distal direction.

In some embodiments, a motor 2107 is configured to drive rotation of afirst gear 2109 which in turn interferes with a second gear 2111(positioned adjacent or on top of gear 2109), causing second gear 2111to rotate. In some embodiments, rotation of second gear 2111 producesrotation of the assembly which includes the driving wheels 2103 and thelinear motor 2105, rotating the assembly (along with the guidewire heldtherein) in its entirety.

In some embodiments, when gear 2109 is rotated, it rotates a holder 2121of the guidewire, rotating (rolling) the guidewire. Therefore, in someembodiments, rotation (roll) of the guidewire is carried out at twolocations along the guidewire: a first location at holder 2121, and asecond location at the assembly which includes the driving wheels andlinear motor—which is rotated, along with the guidewire, as a whole. Apotential advantage of rolling the guidewire at two locations along theguidewire, where optionally one location is proximal to the curve andthe other is distal to the curve, may include reducing twisting of theguidewire during roll, for example by synchronized actuation of rotationat both locations, optionally by executing the roll movement of bothsites by a single motor.

A potential advantage of driving rotation of the guidewire at twolocations along the guidewire length using the same single motor (e.g.via motor 2107 which moves gear 2109) may include improved control overroll of the guidewire, for example as compared to driving rotation atthe two (or more) locations using different motors, which may requiresynchronization between the motors direction and/or speed and/oractuation timing. Another potential advantage of using a same singlemotor for driving rotation at two different guidewire length locationsmay include providing for a more compact, smaller device housing.

Additionally or alternatively, rotation of gear 2109 does not rotate theguidewire directly (such as by not rotating holder 2121), and actuatesrotation of the guidewire which starts only from the point of theassembly that is rotated by gear 2111 (as gear 2111 is rotated by gear2109).

In some embodiments, one or more slip rings are used for supplyingelectrical current to the motors regardless of a current orientation(e.g. rotational orientation) of the assembly. For example, a slip ringconstructed of a reel 2117 and base 2119 is located at the attachment ofthe second gear 2111 to the driving wheels and linear motor assembly. Insome embodiments, the slip ring maintains an electrical coupling to thelinear motor so that the linear motor may be actuated regardless of therotational orientation of the assembly.

In another exemplary construction, shown in FIG. 21B, a motor whichdrives rotation and/or a gear 2113 which transmits rotation from themotor may directly interface with the assembly of the driving wheelsand/or motor 2105 which drives linear movement and/or with a shaft inwhich the tool is received. In an example, gear 2113 is positioned alonga similar long axis as the assembly.

In some embodiments, gear 2113 is formed with a slot 2123 through whichthe guidewire passes. Optionally, slot 2123 forms a direct extension ofa slot 2125 in a designated shaft 2127 in which the guidewire isreceived. In some embodiments, the slot extends along a 5 degrees, 10degrees, 20 degrees arc of the gear circumference. A potential advantageof a slot through the gear may include that removal of the guidewirefrom the actuation mechanism may be facilitated.

FIG. 21C is a cross section view showing an actuation assemblycomprising a shaft 2127 and wheels 2103 which drive linear movement ofthe guidewire. In some embodiments, shaft 2127 defines an elongate innerlumen 2129 in which guidewire is received, the lumen being incommunication with slot 2125. In some embodiments, inner walls of shaft2127 are constructed to match a contour of the wheels (see for examplecurvature 2128) so that a guidewire within lumen 2129 is guided rightinto (and then out from) a path in-between the wheels. In someembodiments, lumen 2129 extends in close proximity to the wheels outercontour, to bring the guidewire directly in-between the wheels.

In some embodiments, wheels 2103 are arranged (lie) on a plane that issubstantially perpendicular to a plane defined by slot 2125.Alternatively, the wheels may be arranged on a plane parallel to a planedefined by slot 2125.

A potential advantage of shaft constructed to match a contour of thewheels may include improved control of the guidewire as it is fed into(and exits out from) the path in between the driving wheels. Anotherpotential advantage may include reducing a risk of slippage and/or othermovement of the guidewire out of its designated path.

A potential advantage of an assembly which includes wheels for drivinglinear movement of the guidewire and which is configured to rotate, as awhole, to generate roll of the guidewire may include that linearmovement can be performed during roll movement (or vice versa). Anotherpotential advantage of a dual-movement assembly where linear movementand rotation are actuated at the same physical location (inside therobotic device) may include reducing slippage or other undesiredguidewire movement which may occur, for example, if two spaced-apartmechanisms were each to drive linear movement and roll movement, and theguidewire would need to extend between them. In spaced apart mechanismswhere one mechanism actuates rotation and another spaced-apart mechanismactuates linear movement, rotation of the guidewire may cause slippageof the guidewire between the rotation mechanism and the linear movementmechanism (or vice versa—linear movement of the guidewire may cause itto slip from the rotation mechanism). Another disadvantage of separatespaced apart mechanisms is the possible induction of friction at theidle site (i.e. the applying of friction onto a tool segment at amechanism which is currently not in use), which may, require some typeof release mechanism that would disengage one mechanism while the otheris operated.

FIG. 22 shows an exemplary arrangement of mechanisms driving movement ofa guidewire, according to some embodiments.

In some embodiments, guidewire rotation is carried out by more than onemechanism. Optionally, two or more mechanisms which engage the guidewireare configured to cause rotation (roll) of the guidewire. In suchsituation, the two mechanisms are controlled in a synchronized manner,for example to ensure that the guidewire is not twisted or kinked.

In some embodiments, a guidewire proximal portion or handle is heldwithin an adaptor or holder 2201, suitable to generate rotation of theguidewire by either rotating to rotate the handle as a whole, and/or byactuating a handle component, such as a rotatable knob (not shown),which generates rotation (roll) of the guidewire (optionally, roll of adistal tip of the guidewire). The guidewire extends from the holder 2201along an axis 2203 about which it rotates, until exiting the housing.When the guidewire renters the housing, it may be passed through asecond mechanism suitable to actuate rotation (and in thisexample—linear movement as well). The second mechanism, for example amechanism as shown in FIG. 21B, may be configured to actuate rotation(roll) of the guidewire about an axis 2205 along which the guidewireextends. Optionally, axis 2205 is parallel to axis 2203, definingparallel paths along which tool actuation takes place. Alternatively,paths of the tools defined along axes 2205 and 2203 are not parallel,for example, angling in or angling out relative to each other.

In some embodiments, the mechanisms extend to a similar height and/oraxial length, so that they can be fitted within a compact housing.

FIGS. 23A-B are a schematic diagram and a flowchart pertaining tocontrolling a length and/or position of a tool by adjusting a curvedportion of the tool, according to some embodiments.

In some embodiments, as schematically illustrated in FIG. 23A, a tool2301 manipulated by the robotic device 2302 is engaged at two or morelocations 2303, 2305 that are spaced apart from each other (along thelength of the device), such that a segment 2307 of the tool extending inbetween the two locations can be adjusted (lengthened or shortened). Insome embodiments, locations 2303, 2305 define attachment points of tool2301 to the robotic device housing 2302, while segment 2307 extendsexternally to the device (i.e. externally to the device housing).

In some embodiments, locations 2303, 2305 are arranged relative to eachother in a manner that causes a bend or curvature of the segment 2307,for example, into a “U” shape curvature as shown. In an example,locations 2303 and 2305 are aligned side-by-side.

Alternatively, locations 2303 and 2305 are not aligned side by side.

In some embodiments, for controlling a length of the tool, the curve(e.g. the “U” shape) is changed in size (e.g. expanded or contracted),changing a maximal distance 2309 between a peak of the curve and thehousing of device 2302.

In some embodiments, an extent of the curve (e.g. as defined by a radiusof curvature 2310) is set by linear movement of the tool (e.g. an extentin which the tool is advanced or retracted) and/or by manual loading ofthe tool, where a certain segment of the tool length is loaded into thesystem. In some embodiments, the extent of the curve depends on a totallength of the tool.

In some embodiments, a distance 2312 between the attachment points ofthe tool to the housing is a function of the radius of curvature 2310 ofthe tool. Optionally, distance 2312 is twice the minimal radius ofcurvature to which the tool can be bent.

In some embodiments, dimensions of housing 2302 such as an extent of awall of the housing in which the entry and exit apertures for the toolare formed is sized in accordance with the radius of curvature of thetool, for example being at least twice a minimal radius of curvature ofthe tool, but no more than 5 times, 6 times, 8 times, 10 times orintermediate, larger or smaller times the minimal radius of curvature ofthe tool intended for manipulation by the device.

In some embodiments, a maximal dimension of the housing (such as a widthof the housing or a height of the housing) is between 5-10 cm, 8-20 cm,12-40 cm or intermediate, longer or shorter.

In some embodiments, the device includes more than two engagementlocations with the tool, allowing for a plurality of curves (e.g. “U”curves) to be formed in between the locations.

A potential advantage of a device that defines tool engagement locationssuch that a tool segment extending in between the locations isadjustable in length may include improving control over a length of thetool being manipulated. Optionally, a length of a most distal toolsegment, such as a segment extending between the last exit from therobotic device housing and a target point inside the patient's body, iscontrolled, thereby potentially allowing fine control of a tool distaltip position. In some embodiments, advancing the tool towards the targetpoint inside the body reduces the size of the curve of the tool outsidethe housing, and vice versa: retracting the tool back from the targetpoint increases the size of the curve.

Another potential advantage of a device that defines tool engagementlocations such that a tool segment extending in between the locations isadjustable in length may include the ability to receive and manipulatetools of various lengths.

Another potential advantage of a device that defines tool engagementlocations such that a tool segment extending in between the locations isadjustable in length may include that the curved segment extendsexternally to the device housing, potentially allowing for a device ofrelatively small dimensions (e.g. axial length) which is substantiallynot affected by the tool length, enabling a compact housing of smalldimensions.

The flowchart of FIG. 23B is an example of the mechanism described bythe diagram of FIG. 23A. In some embodiments, a tool proximal end issecured to the robotic device (2321). For example, a handle of the toolis received by and/or attached to a designated adaptor or holder of thedevice. This attachment may be referred to as a first engagementlocation, for example as described above. In some embodiments, a moredistal portion of the tool is threaded or inserted into the roboticdevice (2323). For example, a more distal portion of the tool isthreaded into a designated shaft of the manipulating mechanism (e.g. aguidewire is inserted to be engaged by the tool-moving wheels). Thissecond attachment may be referred to as the second engagement location,for example as described above.

Then, optionally, a tool segment extending in between the securinglocation of the tool proximal end and the engagement location of thetool (e.g. by the tool-moving wheels) is adjusted in length (2325).

FIG. 24 shows a system configuration defining an arrangement of tools inwhich a tool length can be adjusted, according to some embodiments.

In the example shown, a robotic device 2401 including and/or beingcoupled to a guiding catheter unit 2403 is configured to receive anddrive movement of: a guidewire 2405, a microcatheter 2407, and a guidingcatheter 2409. In some embodiments, as shown in this example, two “U”shaped curves 2411 and 2413 are defined by tools passed through thesystem: curve 2411 of the guidewire alone, and curve 2413 of theguidewire as it extends inside the lumen of the curved microcatheter. Insome embodiments, a change in a size of curve 2413 results in jointmovement of the microcatheter and guidewire at segments that are distalto the curve. In some embodiments, movement of the microcatheter(advancement or retraction) changes the size of curve 2413.

As can be observed in FIG. 24, the device housing 2402 (i.e. the wallsof the housing) define the following apertures through which the toolspass into and/or out from of the inner device space defined by thehousing: in some embodiments, a proximal end portion of guidewire 2405is anchored at a holder 2404 to the device; the guidewire then entersthe housing at an aperture 2406 and exits via an aperture 2408, whereaperture 2408 is optionally located at an opposing wall of the housingto a wall in which aperture 2406 is defined. In some embodiments, aproximal portion of the microcatheter 2407 is anchored to the device ata holder 2410, where also the guidewire is received within themicrocatheter lumen. Then, in some embodiments, the microcatheter entersthe housing at an aperture 2412 and exits the housing at an aperture2414, which is optionally configured at an opposite wall of the housingto aperture 2412.

FIG. 25 schematically illustrates tool-movement driving mechanisms ofthe system, according to some embodiments.

In some embodiments, as shown in this example, tool-movement mechanismsare arranged parallel to each other, for example, aligned side-by-side.A potential advantage of the tool moving mechanisms being parallel toeach other (and optionally aligned along a similar axial extent) mayinclude that a tool extending throughout the mechanisms can beadjustably bent, thus providing for variable tool length. A potentialadvantage of the tool moving mechanisms being parallel to each other(and optionally aligned along the a similar axial extent) may includethat the device housing which accommodates these mechanisms can bemaintained at relatively small, compact dimensions which are notdetermined by the tool actual length.

The tool-movement mechanisms shown herein include a mechanism 2501 forholding and optionally rotating a guidewire 2502 (see for example thedescription of FIG. 21A); a mechanism 2503 for actuating lineartranslation of the guidewire, including for example a set of wheels2505; and a mechanism 2507 for actuating linear translation of amicrocatheter 2508, including for example a set of wheels 2509.

In some embodiments, guidewire rotation may be carried out at one orboth of mechanisms 2501, 2503, optionally under synchronization (such asa by a device controller).

FIGS. 26A-B are examples of a device configuration including elasticelements (e.g. springs) for selectively engaging tools received by thesystem, according to some embodiments.

In some embodiments, elastic elements (e.g. springs, bands) arepositioned and configured to move (e.g. push) the driving wheels towardsa tool received within the device, bringing the wheels into closecontact with the tool. Additionally or alternatively, elastic elementsare positioned and configured to move (e.g. push, center) a toolreceived within the device into operable contact with the drivingwheels.

In the example shown, a spring 2601 is mounted onto a lever 2603 holdingthe driving wheels 2605 so that upon exertion of force onto the spring,the lever moves the wheels into contact with the tool. In someembodiments, force is exerted onto the spring by closure or movement ofa portion of the housing, such as closure of a lid. In some embodiment,the spring is configured to retract the lever to move the wheels awayfrom the tool, for example to allow for removal of the tool. Optionally,the spring is pulled on when the lid (or other portion of the housing)is opened or otherwise moved, thereby moving the wheels away from thetool.

In some embodiments, the spring is pre-configured to exert a forceselected for a specific tool or tool size (e.g. tool diameter), forexample, to position the wheels in contact with a tool of a certainthickness.

FIG. 27 is a schematic block diagram of a robotic device configured formanipulating two or more elongate surgical tools, according to someembodiments.

In some embodiments, walls of a housing 2701 of the robotic devicedefine an inner volume 2703 in which at least two distinct pathways suchas 2705, 2707 for the elongate surgical tools are defined. In someembodiments, the pathways extend across the inner volume, for example,between two opposing walls of the housing, such as wall 2709 and wall2711. Optionally, the housing is shaped in an elongated form, forexample having a substantially rectangular cross section profile, andthe pathways extend along the length of the housing.

In some embodiments, each of the pathways extends between an entryaperture formed at the wall of the housing, and an exit aperture formedat an opposite wall of the housing. In the example shown, pathway 2705extends between entry aperture 2713 formed at wall 2709 and an exitaperture 2715 formed at wall 2711; and pathway 2707 extends between anentry aperture 2717 formed at wall 2711 and an exit aperture 2719 formedat wall 2709.

In some embodiments, an aperture formed in a wall of the housing isshaped and/or sized according to the surgical tool that is passedthrough it. For example, a rounded (e.g. circular) aperture is sized forfitting a cylindrical tool, such as a guidewire or microcatheter, wherethe aperture diameter is optionally no more than 5%, 10%, 25% orintermediate, higher or smaller percentage larger than a diameter of thetool. In some embodiments, an aperture is sized for more than one toolto be passed through. Optionally, the aperture profile is oval (e.g.ellipsoid), rectangular, slot shaped and/or other. In some embodiments,a single elongated slot serves as an aperture for both inner pathways.

In some embodiments, a single tool passes through an entry aperture intothe inner volume of the housing, and exits the housing through arespective exit aperture. Alternatively or additionally, in someembodiments, a plurality of tools telescopically arranged (e.g. 2 tools,such as a guidewire provided within the inner lumen of a microcatheter)pass together through the same entry aperture and exit the housingtogether through a respective exit aperture. Thus, in such an example, afirst tool passes through a first inner pathway, exits the housing intothe lumen of a second tool, and the telescopic assembly of both toolspasses through a second inner pathway. In some embodiments, thetelescopic arrangement of the tools occurs outside of the housing, afterboth tools have passed through their inner pathways, for example, in thecase of a rapid exchange catheter which can be interfaced with theguidewire after each of the guidewire and the rapid exchange catheterhave passed independently through their respective actuation assemblieslocated in the inner pathways.

In some embodiments, the pathways extend in a similar plane, forexample, a similar horizontal plane, a similar vertical plane, a similarplane extending diagonally between the walls of the housing. In someembodiments, the pathways extend along parallel axes. A distance 2721between the parallel axes may range, for example, between 3-12 cm, 2-10cm, 5-9 cm or intermediate, longer or shorter distance.

Alternatively, in some embodiments, the pathways are not parallel, forexample, one pathway extends directly between opposite walls whileanother takes a diagonal or other indirect route.

In some embodiments, except for the aperture locations, the housing issealed. Optionally, the housing includes a removable or moveable coveror lid. In some embodiments, the housing is open at least in part, forexample, shaped as a box with no top face.

In some embodiments, all components which engage the tool to manipulateit and/or to drive its movement are fully encased inside the innervolume of the housing and at least some of these components arepositioned along the pathway defined for the tool. In some embodiments,these components include an actuation assembly, for example thetool-moving elements described in FIGS. 21B-C.

In some embodiments, as shown, a plurality of motors 2722, 2723 isconfigured to drive the actuation assemblies, for example configured todrive tool-moving elements 2725 (e.g. wheels) of each assembly. In someembodiments, the motor and the tool moving elements are positioned alongthe pathway defined for the tool. In some embodiments, the actuationassemblies of the two (or more) pathways are aligned side-by-side. Apotential advantage of the actuation assemblies being aligned side-byside may include allowing for a short or minimal distance 2728(optionally being the device width or height) between opposing walls2733, 2735. In an example, distance 2728 is smaller than 15 cm, 12 cm,10 cm or intermediate, longer or shorter distance.

In some embodiments, the actuation assemblies of the two or morepathways have a similar axial extent (or do not extend beyond a certainaxial extent). A potential advantage of the actuation assemblies beingpositioned relative to each other and/or sized such that they do notextend beyond a certain axial extent may include that a distance 2730between walls 2709 and 2711 (optionally being the device length) may bekept to a minimal axial extent needed to contain the movement drivingcomponents. In an example, distance 2730 is smaller than 10 cm, 7 cm, 12cm or intermediate, longer or shorter distance. In some embodiments, theplurality of motors 2722, 2723 are also positioned within the axialextent of the actuation assemblies, and in proximity to the actuationassemblies, to facilitate the compact design of the device. The abilityto position the motor(s) in close proximity to the actuation assembliesand potentially in contact with at least a portion of the actuationassemblies is provided, for example, due to that no barriers (e.g.sterile protection or shield) are needed between the actuation assembly,the motor(s), and the surgical tool being manipulated.

In some embodiments, the actuation assemblies of the two or morepathways are positioned within the same, shared inner volume defined bythe walls of the housing. In some embodiments, no barriers (e.g. innerwalls, shields, drapes, and the like) exist between the movement drivingcomponents of the two or more pathways. In some embodiments, no barriers(e.g. inner walls, shields, drapes, and the like) exist between theactuation assemblies and the tools that are being manipulated by them.

Alternatively, in some embodiments, a partial partition or barrier areprovided. For example, the device housing may include an inner wall orprotrusion which do not fully block the inner volume, leaving at leastsome regions of the pathways in communication with each other.

In some embodiments, an actuation assembly of an inner pathway (e.g. anactuation assembly that includes a shaft in which a tool is receivedand/or wheels which drive linear movement of the tool) is exposed to anactuation assembly of a different inner pathway, for example an adjacentpathway.

In some embodiments, actuation assemblies of a plurality of pathways arearranged and held with respect to each other on a chassis. Optionally,the chassis is exposed and open to its surroundings, for example, nohousing is provided.

In some embodiments, an actuation assembly of a pathway at leastpartially restrict movement of the tool within the inner pathway, forexample, restricting lateral movement of a tool received within thepathway. For example, movement of the tool out of notional limitsdefined by the elongate pathway is restricted. In some embodiments, thetool is channeled through the pathway, for example, received within aslot of an elongate shaft (such as the shaft of an actuation assembly,e.g. shaft 2127, FIG. 21B). Alternatively or additionally, the pathwayis defined by a path generated between a plurality of pairs of opposingwheels.

In some embodiments, in addition to extending through the pathway, atool engages the device at one or more additional fixation locations(also referred to herein as “securing points”, “engagement points”). Insome embodiments, a fixation location comprises a holder (such as 2727,2729) located outside the housing, inside the housing, or partiallyinside the housing and partially outside the housing. In someembodiments, a fixation location couples a tool to the housing and/or toone or more other tools. For example, at fixation location 2729 a firstelongate surgical tool 2731 which extends through pathway 2705 (e.g. aguidewire) enters an inner lumen of a second elongate surgical tool 2733(e.g. a microcatheter), which is coupled to the housing at fixationlocation 2729. In some embodiments, a proximal end of tool 2731 iscoupled to the housing at fixation location 2727.

In some embodiments, fixation location 2727 is shaped and configured toaccommodate a proximal handle of tool 2731, for example, a handle thatmanipulates the distal portion of the tool in terms of bend and/orstiffness. In some embodiments, an additional motor (not shown) isconfigured for rotating tool 2731 through two locations, one of which isthe handle of the tool (for example at fixation location 2727) and theother is a region more distal of the tool. For example, a motorconfigured for rotating tool 2731 by rotating an actuation assemblywhich is associated with a portion of the tool 2731, is also operablyconnected to the handle of the tool, optionally through a gear system.As such, the motor is configured for rotating the tool simultaneouslyfrom these two distinct locations. An advantage for commencing rollmovement by the same motor in two different locations along the tool mayinclude enhancing the torque applied on the tool and eliminating therisk of slippage of the tool in its gripping locations found in theactuation assembly.

In some embodiments, a fixation location of a tool with the housing(such as 2727) and an entry aperture leading the tool into the innervolume (such as 2713) are located on a same wall of the housing, so thata section of the tool that is found outside the housing forms a curve,for example, a U-shaped curve. In some embodiments, for example asdescribed in FIGS. 23A-B, the extent of the U-curve is dynamicallyadjustable. Optionally, linearly moving the tool (such as via thetool-moving elements, e.g. wheels) changes the extent of the U-curverelative to the external side of the wall of the housing.

In some embodiments, the curve is defined along a path which extendsfrom and to the same wall of the device housing.

In the example shown, the housing comprises sharp corners and straightedge walls, but other configurations are also contemplated, including,for example, rounded corners, curved walls, and the like.

In some embodiments, actuation of the actuation assembly (e.g. via amotor) of each of the pathways is controlled by a controller 2735. Insome embodiments, components of each pathway are controlledindependently, yet in a synchronized manner.

In some embodiments, controller 2735 is controlled remotely by anexternal device, for example by a remote control device such asdescribed herein.

FIG. 28 schematically illustrates a robotic device for manipulation oftwo or more elongate surgical tools configured for a telescopicarrangement, such as in a non-limiting manner a guidewire and amicrocatheter, the first elongate tool extending at least in part withinthe lumen of the second elongate tool, according to some embodiments.

In some embodiments, robotic device 2801 comprises a housing 2803comprised of a plurality of walls which form an inner volume 2805between them. In some embodiments, two or more inner pathways extendinside the inner volume, such that tools 2810, 2813 received andoperated by the device extend, at least in part, along the innerpathways.

In some embodiments, each of the inner pathways includes an actuationassembly positioned at a position of the pathway, for example, axiallyextending along at least a portion of the pathway. In some embodiments,an actuation assembly, such as 2806, 2807, is configured for linearlymoving the tool, for example, one or more sets of wheels configured toadvance and/or retract the tool. Alternatively or additionally, anactuation assembly, such as 2806, is configured for moving the tool in aroll manner, for example by rotating a set of wheels gripping the tooltherebetween.

In some embodiments, actuation assemblies are operably coupled to aplurality of motors, for example motors 2811, 2808, 2809. In someembodiments, the motors are configured for operating the actuationassemblies to generate linear movement of the tools received therein.Alternatively or additionally, the motors are configured to generate aroll movement of the received tool, optionally by generating a rollmovement of the tool's associated actuation assembly as a whole. Forexample, motor 2809 is operably connected to linear movement mechanism2807, optionally via a gear system, and is configured to rotate linearmovement mechanism 2807 together with motor 2811, thereby rolling tool2810 which is gripped within linear movement mechanism 2807. A potentialadvantage for rotating the entire linear movement mechanism along withthe tool is a simplification of the associated gear system, and theenablement of simultaneous operation of linear and roll movementtogether. Rolling of motor 2811 together with the linear movementmechanism 2806 is enabled, in some embodiments, due to that no sterilebarrier exists between the motors and the actuation assemblies.

In the example shown, a first elongate surgical tool 2810 (e.g. aguidewire) extends along a first inner pathway, for example between anentry aperture 2814 into the housing and an exit aperture 2816 from thehousing.

In some embodiments, linear movement of tool 2810 is driven by motor2811, and roll of tool 2810 is driven by motor 2809, both located andconfigured at a position of the inner pathway (e.g. along a notionalaxis defined by the pathway across the inner volume).

In some embodiments, at the exit aperture 2816 of tool 2810 from thehousing, the tool 2810 is telescopically received within a lumen of asecond elongate surgical tool 2813, for example, a microcatheter. Tool2813, in turn, enters the housing at an entry aperture 2815 and extendsalong a second inner pathway to an exit aperture 2817, with tool 2810extending inside it.

In some embodiments, linear movement of the tool 2813 is driven byactuation assembly 2807.

In some embodiments, the actuation mechanism(s) and the plurality ofmotors all share the same inner volume, with no barrier or otherphysical separation therebetween.

FIG. 29 schematically illustrates another exemplary embodiment of therobotic device configured for receiving three telescopically arrangedelongate surgical tools, for example, a guidewire, a microcatheter and aguiding catheter.

In some embodiments, robotic device 2901 comprises a housing 2903 havingan inner volume 2905, wherein entry aperture 2914 and exit aperture 2916define, between them, a first inner pathway for receiving a firstelongated surgical tool 2910, and entry aperture 2915 and exit aperture2917 define, between them, a second inner pathway for receiving a secondelongate surgical tool 2913.

In some embodiments, actuation assemblies 2906, 2907 are positionedalong the inner pathways and configured to come into contact with thetools received therein for at least one of advance, retract and/or rollthe tool. In some embodiments, a plurality of motors, such as motors2909, 2911 and 2908, are positioned in proximity to the inner pathwaysand are operably connected to the actuation assemblies. In someembodiments, the motors and the actuation assemblies are found withinthe same inner volume accommodating the inner pathways, for examplewithout barriers blocking the air circulating between them.

In some embodiments, only one motor is operably connected to anactuation assembly, as exemplified by actuation assembly 2907 and motor2908, which is operably connected to the actuation assembly to advanceor retract elongate surgical tool 2913. In some embodiments, two or moremotors are operably connected to an actuation assembly, as exemplifiedby actuation assembly 2906 and motors 2909 and 2911. In this example,motors 2909 and 2911 are operably connected to actuation assembly 2906to advance, retract and roll elongate surgical tool 2910. Optionally,motor 2909 rolls tool 2910 by rolling the complex 2904, wherein complex2904 comprises at least actuation assembly 2906 and motor 2911.

In some embodiments, the proximal end of elongate surgical tool 2910 issecured to a fixation location 2920. In some embodiments, fixationlocation 2920 includes a protrusion configured to attach to a luer (notshown) optionally found in the proximal end of tool 2910. Alternatively,fixation location 2920 comprises a cavity sized and shaped toaccommodate a handle (not shown) optionally found at the proximal end oftool 2910. In some embodiments, the proximal end of tool 2910 isoperably connected to adaptor 2950 which, in some embodiments, causesthe tool to roll around its longitudinal axis, for example by roll of aproximal handle portion of the tool which is received at the adaptor. Insome embodiments, the motor which is operably connected to the adaptorto induce the roll movement, is the same motor operably connected to theactuation assembly associated with the tool at a more distal location.For example, as shown and exemplified through motor 2909, which isoperably connected to adaptor 2905 and at the same time operablyconnected to complex 2904, to cause roll actuation of tool 2910 from atleast these two distinct locations.

In some embodiments, a U-shape curve is formed in tool 2910 betweenfixation location 2920 and entry aperture 2914. In some embodiments,when tool 2910 is moved linearly in actuation assembly 2906 it causesthe distal end 2930 of tool 2910 to advance or retract, optionally whena distal portion has been introduced into the patient's body. In someembodiments, as tool 2910 is advanced or retracted, a distance between amaximal point of the U-shape curve and housing 2903 is shortened orlengthened. An advantage of the U-shape curve being formed outside ofhousing 2903 is that the housing size does not need to accommodate thisdistance, and the device is capable of navigating a range of toollengths, with no dependency on the size of the device.

In some embodiments, a fixation location of one elongate surgical toolis found at the exit aperture of another elongate surgical tool, asshown and exemplified in fixation point 2922, which overlaps with exitaperture 2916, and as such, causes elongate surgical tool 2910 to exithousing 2903 through exit aperture 2916 directly into the lumen ofelongate surgical tool 2913, when tool 2913 is connected to fixationlocation 2922.

In some embodiments, a second U-shaped curve for tool 2910 and a firstU-shaped curve for tool 2913 are formed between fixation location 2922and entry aperture 2915. In some embodiments, when advancing orretracting the distal end 2940 of tool 2913, both tool 2910 and tool2913 are moved to lengthen or shorten the distance between the maximalpoint of the joint curve and housing 2903. In some embodiments, when itis desired to linearly translate the distal end 2940 (of tool 2913)without translating distal end 2930 (of tool 2910), motor 2911 linearlytranslates tool 2910 at an opposite direction to the translation ofmotor 2907 which affects both tools, thereby, causing the distal end2930 of tool 2910 to effectively to stand in place.

In some embodiments, an elongate surgical tool (for example, a guidecatheter, or sheath) connected to a fixation location from outside ofhousing 2903 is configured to be operated by motors residing insidehousing 2903, for example, elongate surgical tool 2919 connected tofixation location 2917 and can be linearly moved actuation assembly2927, operably connected to motor 2928 and motor 2929 for linear androll movement, respectively. In some embodiments, actuation assembly2927 together with motors 2928 and 2929 all reside in the same innervolume as motors 2909, 2911 and 2908 and in the same inner volume as theactuation assemblies they are operably connected to, 2906 and 2907. Insuch exemplary embodiments, at least 5 motors reside within the sameinner volume as the inner pathways of the elongate surgical tools 2910and 2913.

In some embodiments, fixation location 2924 overlaps with exit aperture2917, such that the telescopically arranged elongate surgical tools 2910and 2913 exit housing 2903 through exit aperture 2917, directly into thelumen of elongate surgical tool 2919. In some embodiments, actuationassembly 2927 is positioned along the same inner pathway as that of tool2913.

As used herein, the terms “insertion device” and “medical device”,“robotic device”, “robotic system”, “device”, “system” and the like mayinterchangeably be used. In some instances, a device is addressed aspart of a system.

As used herein, the terms “medical instrument” and “medical tool”,“surgical tool”, “elongate tool” and the like may interchangeably beused.

Although some examples described throughout this disclosure mainlyrelate to insertion of a guidewire into the patient's blood vessel, thisis done for simplicity reasons alone, and the scope of this disclosureis not limited to devices for insertion of guidewires alone, but mayinclude insertion of additional medical tools/instruments, such as,microcatheters, balloon catheters, etc. Further, the scope of thisdisclosure is not limited to insertion of medical tools into bloodvessels, but it may include insertion of medical tools into other bodilylumens, such as the urethra, gastrointestinal tract and the trachea. Inthe description and claims of the application, the words “include” and“have”, and forms thereof, are not limited to members in a list withwhich the words may be associated.

The terms “comprises”, “comprising”, “includes”, “including”, “having”and their conjugates mean “including but not limited to”.

The term “consisting of” means “including and limited to”.

The term “consisting essentially of” means that the composition, methodor structure may include additional ingredients, steps and/or parts, butonly if the additional ingredients, steps and/or parts do not materiallyalter the basic and novel characteristics of the claimed composition,method or structure.

As used herein, the singular form “a”, “an” and “the” include pluralreferences unless the context clearly dictates otherwise. For example,the term “a compound” or “at least one compound” may include a pluralityof compounds, including mixtures thereof.

Throughout this application, various embodiments of this invention maybe presented in a range format. It should be understood that thedescription in range format is merely for convenience and brevity andshould not be construed as an inflexible limitation on the scope of theinvention. Accordingly, the description of a range should be consideredto have specifically disclosed all the possible subranges as well asindividual numerical values within that range. For example, descriptionof a range such as from 1 to 6 should be considered to have specificallydisclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numberswithin that range, for example, 1, 2, 3, 4, 5, and 6. This appliesregardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is meant to includeany cited numeral (fractional or integral) within the indicated range.The phrases “ranging/ranges between” a first indicate number and asecond indicate number and “ranging/ranges from” a first indicate number“to” a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numerals therebetween.

As used herein the term “method” refers to manners, means, techniquesand procedures for accomplishing a given task including, but not limitedto, those manners, means, techniques and procedures either known to, orreadily developed from known manners, means, techniques and proceduresby practitioners of the chemical, pharmacological, biological,biochemical and medical arts.

As used herein, the term “treating” includes abrogating, substantiallyinhibiting, slowing or reversing the progression of a condition,substantially ameliorating clinical or aesthetical symptoms of acondition or substantially preventing the appearance of clinical oraesthetical symptoms of a condition.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseelements.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims.

It is the intent of the applicant(s) that all publications, patents andpatent applications referred to in this specification are to beincorporated in their entirety by reference into the specification, asif each individual publication, patent or patent application wasspecifically and individually noted when referenced that it is to beincorporated herein by reference. In addition, citation oridentification of any reference in this application shall not beconstrued as an admission that such reference is available as prior artto the present invention. To the extent that section headings are used,they should not be construed as necessarily limiting. In addition, anypriority document(s) of this application is/are hereby incorporatedherein by reference in its/their entirety.

What is claimed is:
 1. A compact robotic device for driving movement oftwo or more elongate surgical tools when said two or more elongatesurgical tools are at least partially received within said device, saiddevice comprising: a housing comprising walls which define an innervolume including at least two inner pathways for accommodating said twoor more elongate surgical tools; said housing encasing: a plurality ofmotors; two or more tool actuation assemblies configured at a positionof each of said two or more inner pathways; said actuation assembliesdriven by said plurality of motors and configured to operably contact anelongate surgical tool at least partially received in the inner pathwayto at least one of advance, retract and/or roll said elongate surgicaltool.
 2. The device according to claim 1, wherein each of said two ormore inner pathways extends across said inner volume between an entryaperture and an exit aperture, said entry aperture and said exitaperture being configured on opposite walls of said device housing andin communication with said inner volume.
 3. The device according toclaim 1, wherein no inner barrier exists between said two or more innerpathways such that said two or more tool actuation assemblies and saidplurality of motors all share said inner volume with no separationtherebetween.
 4. The device according to claim 2, wherein at least onefixation location is defined externally to said walls of said housingfor securing a proximal end of an elongate surgical tool to the housing.5. The device according to claim 4, wherein said at least one fixationlocation is located at one of said exit apertures, such that an elongatesurgical tool exiting said inner volume through said exit aperture isled into a lumen of a proximal end of a second elongate surgical tool,forming a telescopic arrangement of the two tools.
 6. The deviceaccording to claim 4, wherein said at least one fixation location andone of said at least two entry apertures are defined along the same wallof the housing such that an elongate surgical tool secured to saiddevice at said at least one fixation location forms a curve beforeentering said inner volume through said at least one entry aperture. 7.The device according to claim 1, wherein said two or more inner pathwaysare parallel to each other and have a similar axial extent.
 8. Thedevice according to claim 1, wherein a distance between long axes ofsaid inner pathways is shorter than 10 cm.
 9. The device according toclaim 1, wherein said tool actuation assemblies are both confined withinsaid walls of said housing, and wherein only portions of said two ormore elongate surgical tools, when received within said device, extendoutwardly from said walls of said housing to a distance of at least 1 cmaway from said housing.
 10. The device according to claim 1, whereinsaid inner volume is smaller than 2800 cm{circumflex over ( )}3 andwherein said device has a weight of less than 850 grams.
 11. The deviceaccording to claim 3, wherein said plurality of motors comprises 3-5motors.
 12. The device according to claim 1, wherein each of saidactuation assemblies comprises: a designated elongate shaft extendingaxially along at least a portion of a length of said inner pathway forsaid elongate surgical tool to extend through; and at least one pair ofwheels positioned adjacent said shaft and protruding inside said shaftto operably contact the elongate surgical tool received within saidshaft.
 13. The device according to claim 1, wherein each of saidactuation assemblies comprises a plurality of wheels pairs, each wheelpair comprising a set of opposing wheels arranged to define said innerpathway therebetween.
 14. The device according to claim 12, wherein saidat least one pair of wheels comprises a set of opposing wheelsconfigured to rotate to advance or retract said elongate surgical toolwithin said shaft.
 15. The device according to claim 12, wherein saidshaft is connected to a gear which when rotated rotates said shaft alongwith said plurality of wheels and with said elongate surgical toolreceived therein about the shaft long axis, thereby rolling saidelongate surgical tool.
 16. The device according to claim 1, whereindimensions of said housing include a height shorter than 30 cm, a widthshorter than 30 cm, a length shorter than 30 cm; wherein each of saidinner pathways extends axially along said length.
 17. The deviceaccording to claim 2, wherein said housing, at at least one of saidentry aperture and/or at at least one of said exit aperture, comprises aconically shaped protrusion having a rounded external lip.
 18. Thedevice according to claim 1, wherein said housing comprises a removableor movable cover providing access to the one or more elongate surgicaltools loaded onto said device and extending along at least a portion ofsaid inner pathways.
 19. The device according to claim 1, wherein saiddevice is configured to drive movement of a guidewire and amicrocatheter, the guidewire configured to at least partially extendthrough a lumen of said microcatheter.
 20. The device according to claim1, comprising a controller configured to control said plurality ofmotors for driving said two or more actuation assemblies.
 21. The deviceaccording to claim 20, wherein said controller is controlled remotely byan external remote control device.
 22. A kit comprising: a deviceaccording to claim 1; a guidewire for loading onto said device such thatat least a portion of said guidewire extends along one of said innerpathways; a microcatheter for loading onto said device such that atleast a portion of said microcatheter extends along a second of saidinner pathways.
 23. A surgical system comprising: a robotic deviceaccording to claim 1; an add-on unit for driving movement of a guidingcatheter, said add-on unit mechanically attachable to said housing ofsaid robotic device.